Speedlock 8516-04-26/1358

by National Advanced Endoscopy Devices, Inc.

Speedlock 8516-04-26/1358 is a Class II device made by National Advanced Endoscopy Devices, Inc., listed in FDA GUDID since 6 Jan 2017 (UDI-DI 00848657061834), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00848657061834 UDI-DI	Date6 Jan 2017Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00848657061834

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Speedlock
Generic name: Rigid endoscopic tissue manipulation forceps, reusable
Model / reference: 8516-04-26/1358
Description: Needle Holder, 5mm, with TC Inserts Handle: 1358 Axial Thumb Release, 26cm Length

Primary DI / UDI-DI: 00848657061834
FDA product code: GEI
GMDN term: Rigid endoscopic tissue manipulation forceps, reusable

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

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Lot / batch number
Serial number

Other properties (11, all answered No)