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Disposable Needle Guide 5145

by Protek Medical Products, Inc.

Part of a family of 41 devices: see the family page

Ref 1-735-5145

Disposable Needle Guide 5145 is a needle guide (EU MDR Class I; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Protek Medical Products, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 084191215000NSMV), cleared under FDA 510(k) K971722 on 10 Jul 1997 (1 earlier submission) and listed in FDA GUDID since 25 Apr 2017 (UDI-DI 10841912104939), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K971722

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084191215000NSMV Basic UDI-DI 10841912104939UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841912104939 UDI-DI Date25 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK971722 Date10 Jul 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084191215000NSMV registered 27 Oct 2026 Active
  • FDA 510(k) K971722 decided 10 Jul 1997 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10841912104939 listed 25 Apr 2017 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

4 dated events

  1. Cleared FDA 510(k) K971115
  2. Cleared FDA 510(k) K971722
  3. Listed FDA GUDID 10841912104939
  4. Registered EUDAMED 084191215000NSMV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
aspen surgical® EUDAMED
Disposable Needle Guide GUDID
Generic name
Needle guide, single-use
Device name
Needle Guides (non sterile)
Model / reference
1-735-5145 EUDAMED
5145 GUDID
Primary DI / UDI-DI
10841912104939
Basic UDI-DI
084191215000NSMV
510(k) Number
FDA product code
ITX
EMDN code
A018002 Needle guides
GMDN term
Needle guide, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1-735-5145
GUDID
5145
Device classEUDAMED
Class I
GUDID
Class II
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 10841912104939: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Needle guide, single-use

Cleared under the same submission (K971115)

and 8 more cleared under K971115

Cleared under the same submission (K971722)

and 8 more cleared under K971722

Similar devices in this category

Other devices filed under NEEDLE GUIDES.

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Lot / batch number
Other properties (22, all answered No)