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Devices
Anspach Cutters and Attachments
Model / Serial
All Lots for MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
Product Description
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) || MCA - MICRO CURVED ATTACHMENT, || MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, || MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, || MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, || MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, || MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, || MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, || MCA5-1SB - lMM FLUTED BALL, 5.6CM, || MCA5-1SD - lMM DIAMOND BALL, 5.6CM, || MCA5-2SB - 2MM FLUTED BALL, 5.6CM, || MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, || MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, || MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, || MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, || MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, || MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, || MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, || MCA7-1SB - lMM FLUTED BALL, 7.3CM, || MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, || MCA7-2SB - 2MM FLUTED BALL, 7.3CM and || MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. || The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
Manufacturer
The Anspach Effort, Inc.
1 Event
Recall of Anspach Cutters and Attachments
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Manufacturer
The Anspach Effort, Inc.
Manufacturer Address
The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA
Language
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