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Driva™ TSV3.8DSN

by ZimVie US Corp LLC

Part of a family of 217 devices: see the family pagePart of a family of 136 devices: see the family page

Ref TSV3.8DSN

Driva™ TSV3.8DSN is a device classified as Class IIa in the EU and Class I in the US made by ZimVie US Corp LLC, registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI 844868AFJ2) and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 00889024019188), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868AFJ2 Basic UDI-DI 00889024019188UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024019188 UDI-DI Date18 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868AFJ2 registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI 00889024019188 listed 18 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024019188
  2. Registered EUDAMED 844868AFJ2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Driva™ Drills EUDAMED
Driva™ GUDID
Generic name
Fixture/appliance dental drill bit, reusable
Device name
Sterile powered surgically invasive instrument
Sterile Powered Surgically Invasive Instrument – Intended for Reprocessing
Model / reference
TSV3.8DSN
Primary DI / UDI-DI
00889024019188
Basic UDI-DI
844868AFJ2, 844868CAHW
FDA product code
DZA
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00889024019188: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDGUDIDYesEUDAMED
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)