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Tspace Peek/Xp

by Aesculap AG 27 variants

Ref SN386R, SN354R, SN304R, SN301R, SN355R, SN357R

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000006382N Basic UDI-DI Date18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964479496 UDI-DI Date8 May 2020ListedStatusListed GUDID: not 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  • Withdrawn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

Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Surgical instrument/implant rack
Device Name
PROSPACE/TSPACE implantation instr. IIa
PROSPACE/TSPACE implantation instr. I
PROSPACE/TSPACE instrument tray
Model / Ref / Catalog
SN386R, SN357R, SN304R, SN355R, SN301R, SN354R
Primary DI / UDI-DI
04046964479496, 04046964479403, 04046964603570, 04046964479281, 04046964553912, 04046964479274
Basic UDI-DI
40392390000006382N, 40392390000006162C, 40392390000006192J
Direct Marketing DI
04046964479496
04046964479274
04046964603570
04046964553912
04046964479281
04046964479403
FDA Product Code
HWT, FSM
EMDN Code
L091199, S010401
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Surgical instrument/implant rack
Device Class
Class IIa EUDAMED
Class I EUDAMEDGUDID
Regulation Number
888.4800, 878.4800
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
Class I
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No