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HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ DYNACORD

by Medos International SARL 3 variants

Ref 222037, 222375Model HEALIX ADVANCE PEEK DYNACORD, General Orthopedic Use Aiming and Guiding Instruments

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0886705a00081KH Basic UDI-DI Date18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10886705029549 UDI-DI Date16 Apr 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ DYNACORD EUDAMED
Healix Advance EUDAMEDGUDID
HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD GUDID
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable
Cannulated surgical drill bit, reusable
Device Name
HEALIX ADVANCE PEEK Anchor, DYNACORD Suture, White/Blue/Green, White/Black, Blue, Striped, Needle
Model / Ref / Catalog
HEALIX ADVANCE PEEK DYNACORD, 222037, 222375, General Orthopedic Use Aiming and Guiding Instruments
Primary DI / UDI-DI
10886705029549, 10886705029358
Basic UDI-DI
0886705a00081KH, 0886705a00120K2
Direct Marketing DI
10886705029358
510(k) Number
FDA Product Code
MBI, LXH
EMDN Code
P09120102, L0999
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Cannulated surgical drill bit, reusable
Device Class
Class IIb EUDAMED
Class I EUDAMEDGUDID
Class II GUDID
Regulation Number
888.3040, 888.4540
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class I
GUDID
Class I
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterile YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Sutures
  • CMR Substance
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID

Other properties (15)

  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No