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Director Sterile Disposable Needle Guide 4019

by Protek Medical Products, Inc.

Ref 1-535-4019BI

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084191215000STNE Basic UDI-DI 00841912101023UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841912101023 UDI-DI Date16 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
aspen surgical® EUDAMED
Director Sterile Disposable Needle Guide GUDID
Generic Name
Needle guide, single-use
Device Name
Needle Guides (sterile)
Model / Ref / Catalog
1-535-4019BI EUDAMED
4019 GUDID
Primary DI / UDI-DI
00841912101023
Basic UDI-DI
084191215000STNE
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1-535-4019BI
GUDID
4019
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Needle guide, single-use

Cleared under the same submission (K973958)

Show all (12)

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No