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Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Device Name
TENDON SEIZING INSTR STR 6" FDA UDI
Model / Reference
47-3530 FDA UDI
Description
TENDON SEIZING INSTR STR 6" FDA UDI

Identifiers

Primary DI / UDI-DI
10649111212925 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable

Sklar® by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical soft-tissue manipulation forceps, scissors-like, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI 7df09ac3-5ece-4fd2-8d45-1ec02d9173a1 33 fields · synced May 30, 2026