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Hi-Line Xs GE396SU

by Aesculap, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04038653463282 UDI-DI Date7 Jun 2016ListedStatusListed 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  • Withdrawn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
Hi-Line Xs
Generic Name
Orthopaedic bur, single-use
Model / Ref / Catalog
GE396SU
Primary DI / UDI-DI
04038653463282
FDA Product Code
GEY
GMDN Term
Orthopaedic bur, single-use
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
Not in Commercial Distribution

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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