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Rt-Tsv

by ZimVie US Corp LLC

Part of a family of 7 devices: see the family page

Ref RT-TSV

Rt-Tsv is a Class I device made by ZimVie US Corp LLC, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 844868A4GY) and listed in FDA GUDID since 5 Sep 2017 (UDI-DI 00844868040880), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868A4GY Basic UDI-DI 00844868040880UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868040880 UDI-DI Date5 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868A4GY registered 27 May 2026 Active
  • FDA GUDID UDI-DI 00844868040880 listed 5 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868040880
  2. Registered EUDAMED 844868A4GY

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  • Withdrawn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
Tapered Screw-Vent®
Generic name
Dental implant x-ray template
Device name
Dental Implant Transparencies
Model / reference
RT-TSV
Primary DI / UDI-DI
00844868040880
Basic UDI-DI
844868A4GY
FDA product code
HWT
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant x-ray template
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
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 00844868040880: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Dental implant x-ray template

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)