← Back to catalogue

Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Open-surgery dissector FDA UDI
Device Name
OLIVECRONA DISSECT HVY 7.25" FDA UDI
Model / Reference
50-4511 FDA UDI
Description
OLIVECRONA DISSECT HVY 7.25" FDA UDI

Identifiers

Primary DI / UDI-DI
10649111181283 FDA UDI
FDA Product Code
KBM FDA UDI
GMDN Term
Open-surgery dissector FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: Open-surgery dissector

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

Similar devices

Also classified as Open-surgery dissector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI f0bc4e8b-5a42-46c5-8e7c-03f50481087c 33 fields · synced May 30, 2026