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GBR System

FDA UDI

Class II (US FDA UDI)

by Surgident

Identity

Trade Name
GBR System FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Model / Reference
SDP-S36-022 FDA UDI

Identifiers

Primary DI / UDI-DI
08800041000210 FDA UDI
510(k) Number
K170697 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System by Surgident — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.

Cleared under the same submission

K170697 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgident

Sources (1)

  • FDA UDI 07642d91-5d18-4a83-8869-1ebc4377c205 33 fields · synced Jun 8, 2026