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Na 111619

by MAKO Surgical Corp.

Ref 111619Model 08858251002249SS

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002249SS Basic UDI-DI 00848486016821UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486016821 UDI-DI Date24 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
Mako
Generic Name
Surgical support tape, non-bioabsorbable
Device Name
TD-03 - MAKO - Class I (s) - Single-Use - Plastic
Model / Ref / Catalog
111619, 08858251002249SS
Primary DI / UDI-DI
00848486016821
Basic UDI-DI
08858251002249SS
Direct Marketing DI
00848486016821
FDA Product Code
GAD
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
GMDN Term
Surgical support tape, non-bioabsorbable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Surgical support tape, non-bioabsorbable

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Lot / Batch Number: No
  • Manufacturing Date: No