Scalpel SN56

by Treace Medical Concepts, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810111227353 UDI-DI	Date5 Jun 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Scalpel
Generic Name: Scalpel, single-use
Model / Reference: SN56

Primary DI / UDI-DI: 00810111227353
FDA Product Code: GDX
GMDN Term: Scalpel, single-use

Device Class: Class I
Regulation Number: 878.4800
GUDID distribution status: In Commercial Distribution

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Class I
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Class I

See all devices from Treace Medical Concepts, Inc. →

Properties

Sterile
Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (7)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No