Skip to content

NA surgically Invasive Instruments

by Institut Straumann SA 183 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630031778215 UDI-DI Date3 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
surgically Invasive Instruments, 066.5076
Description
Straumann iGuide Drill Ø 2.8mm, L 10mm, for T-sleeve Ø 3.9 mm, stainless steel
Primary DI / UDI-DI
07630031778215
FDA Product Code
NDP
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.8 Millimeter
Length — 10 Millimeter

Other devices from Institut Straumann SA

See all devices from Institut Straumann SA →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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