Adtec Monopolar PO961R

by Aesculap, 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	Number04046964668739 UDI-DI	Date10 Aug 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Adtec Monopolar
Generic Name: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Model / Ref / Catalog: PO961R

Primary DI / UDI-DI: 04046964668739
FDA Product Code: GEI
GMDN Term: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Device Class: Class II
Regulation Number: 878.4400
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No