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EMERGE MEDICAL & Design 310.510.EM

by Emerge Medical

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Overview

EMERGE MEDICAL & Design's Bit Drill, a high-quality orthopedic surgical instrument, is designed for creating holes in bone with precision and ease. This reusable bit is ideal for various medical procedures, including joint replacements, spinal fusions, and other orthopedic treatments.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886020015572 UDI-DI Date8 Jul 2015ListedStatusListed 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  • Withdrawn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
EMERGE MEDICAL & Design
Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
310.510.EM
Primary DI / UDI-DI
00886020015572
FDA Product Code
HTW
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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See all devices from Emerge Medical →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • 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
  • Manufacturing Date: No