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PediNail 01-1500-021-S

by Orthopediatrics Corp.

Part of a family of 67 devices: see the family page

Ref 01-1500-021-SModel 01-1007-0028

PediNail 01-1500-021-S is a device classified as Class IIa in the EU and Class I in the US made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 08411321CIIADB3F) and listed in FDA GUDID since 5 Jun 2025 (UDI-DI 00841132195604), 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 Number08411321CIIADB3F Basic UDI-DI 00841132195604UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132195604 UDI-DI Date5 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIADB3F registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00841132195604 listed 5 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132195604
  2. Registered EUDAMED 08411321CIIADB3F

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  • Withdrawn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
Orthopediatrics® Instrumentation EUDAMED
PediNail GUDID
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
01-1500-021-S, 01-1007-0028
Primary DI / UDI-DI
00841132195604
Basic UDI-DI
08411321CIIADB3F
FDA product code
GFG
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)