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Fastclamp

FDA UDI

Class II (US FDA UDI)

by Surgical Innovations Limited

Identity

Trade Name
Fastclamp FDA UDI
Generic Name
Medical table clamp FDA UDI
Device Name
FASTCLAMP SYSTEM FastClamp Bariatric Bar Medical Table Clamp FDA UDI
Model / Reference
BC-1090-02 FDA UDI
Description
FASTCLAMP SYSTEM FastClamp Bariatric Bar Medical Table Clamp FDA UDI

Identifiers

Primary DI / UDI-DI
05051986011615 FDA UDI
510(k) Number
K100442 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Medical table clamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Fastclamp by Surgical Innovations Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K100442 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Innovations Limited

Sources (1)

  • FDA UDI 7fc9198b-3339-4dd9-92ef-e250f3977d66 35 fields · synced May 30, 2026