Devices

DuraGuard Dural Repair Patch

Model / Serial
Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125
Product Classification
Neurological Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution.
Product Description
Dura Guard, Dural Repair Patch with Apex Processing. || For use as a dura substitute for the closure of dura mater during neurosurgery. || Product Code: || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN
Manufacturer
Synovis Surgical Innovations, Inc.
1 Event
- Recall of DuraGuard Dural Repair Patch

Manufacturer

Synovis Surgical Innovations, Inc.

Manufacturer Address
Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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