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Durasis

FDA UDI

Class II (US FDA UDI)

by Cook Biotech Incorporated

Identity

Trade Name
DURASIS FDA UDI
Generic Name
Dura mater biomatrix implant FDA UDI
Device Name
Durasis Dural Graft FDA UDI
Model / Reference
NXDUR0710 FDA UDI
Description
Durasis Dural Graft FDA UDI

Identifiers

Catalog Number
NXDUR0710 FDA UDI
Primary DI / UDI-DI
00810179630027 FDA UDI
510(k) Number
K160869 FDA UDI
FDA Product Code
GXQ FDA UDI
FTM FDA UDI
GMDN Term
Dura mater biomatrix implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5910 FDA UDI
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Dura mater biomatrix implant

Durasis by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dura mater biomatrix implant.

Cleared under the same submission

K160869 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Biotech Incorporated

Sources (1)

  • FDA UDI c8c7ab7a-0418-477b-a5e4-891516d98243 36 fields · synced May 31, 2026