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Instrapac 8364

by Robinson Healthcare Limited

Instrapac 8364 is a Class I device made by Robinson Healthcare Limited, listed in FDA GUDID since 23 Jun 2025 (UDI-DI 05010058083646), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05010058083646 UDI-DI Date23 Jun 2025ListedStatusListed 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  • Withdrawn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
Instrapac
Generic name
Suturing needle holder, single-use
Model / Ref / Catalog
8364
Primary DI / UDI-DI
05010058083646
FDA product code
GDF
GMDN term
Suturing needle holder, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Size
Length — 12.5 Centimeter

Related devices

Category: Suturing needle holder, single-use

Other devices from Robinson Healthcare Limited

See all devices from Robinson Healthcare Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)