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Super Bypass SBTi-70N-45

by Takayama Instruments Inc.

Super Bypass SBTi-70N-45 is a Class I device made by Takayama Instruments Inc., listed in FDA GUDID since 26 Jun 2025 (UDI-DI 04580036673905), 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

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580036673905 UDI-DI Date26 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  • Withdrawn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
Super Bypass
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
SBTi-70N-45
Primary DI / UDI-DI
04580036673905
FDA product code
MDM
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Suturing needle holder, reusable

Other devices from Takayama Instruments Inc.

See all devices from Takayama Instruments Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)