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Sklar® 10-1634

by Sklar Corporation

Sklar® 10-1634 is a Class I device made by Sklar Corporation, listed in FDA GUDID since 12 Nov 2018 (UDI-DI 10649111360275), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10649111360275 UDI-DI Date12 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sklar®
Generic name
Surgical instrument maintenance lubricant
Model / reference
10-1634
Primary DI / UDI-DI
10649111360275
FDA product code
FSM
GMDN term
Surgical instrument maintenance lubricant
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)