← Back to catalogue

Sklar

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar FDA UDI
Generic Name
Dura mater dissector FDA UDI
Device Name
PENFIELD DISS SIZE 1 DE W/SHRP CUP FDA UDI
Model / Reference
47-2255 FDA UDI
Description
PENFIELD DISS SIZE 1 DE W/SHRP CUP FDA UDI

Identifiers

Primary DI / UDI-DI
10649111015182 FDA UDI
FDA Product Code
KBM FDA UDI
GMDN Term
Dura mater 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: Dura mater dissector

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

Similar devices

Also classified as Dura mater 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 0e824a6f-e40a-4242-9c78-1a0273d43bad 33 fields · synced Jun 8, 2026