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OcciGuide 048-1000

by Biotex, Inc.

OcciGuide 048-1000 (ER GUIDE 1010), a needle guide (FDA Class I; FDA product code GDF, Guide, Needle, Surgical) made by Biotex, Inc., was listed in FDA GUDID on 25 Feb 2021 (UDI-DI M710ERGUIDE10100); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 NumberM710ERGUIDE10100 UDI-DI Date25 Feb 2021ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
OcciGuide
Generic name
Needle guide, single-use
Model / Ref / Catalog
048-1000, ER GUIDE 1010
Primary DI / UDI-DI
M710ERGUIDE10100
FDA product code
GDF
GMDN term
Needle guide, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code GDF (Guide, Needle, Surgical).

Other devices from Biotex, Inc.

See all devices from Biotex, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)