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Sterile Disposable Endocavity Needle Guide Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1-535-9005

by Protek Medical Products, Inc.

Identity

Trade Name
aspen surgical® EUDAMED
Sterile Disposable Endocavity Needle Guide Kit FDA UDI
Generic Name
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Device Name
Needle Guides (sterile) EUDAMED
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3 FDA UDI
Model / Reference
1-535-9005 EUDAMED
9005 FDA UDI
Description
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3 FDA UDI

Identifiers

Catalog Number
9005 FDA UDI
Primary DI / UDI-DI
00841912105267 EUDAMEDFDA UDI
Basic UDI-DI
084191215000STNE EUDAMED
510(k) Number
K970893 FDA UDI
K971115 FDA UDI
K971722 FDA UDI
FDA Product Code
ITX FDA UDI
KKX FDA UDI
EMDN Code
A018002 NEEDLE GUIDES EUDAMED
GMDN Term
Body-orifice ultrasound imaging transducer cover, basic FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
878.4370 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, single-useBody-orifice ultrasound imaging transducer cover, basic

Sterile Disposable Endocavity Needle Guide Kit by Protek Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Body-orifice ultrasound imaging transducer cover, basic.

Cleared under the same submission

K970893 also covers:

K971115 also covers:

K971722 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Protek Medical Products, Inc.

Sources (2)

  • FDA UDI 52d3643d-6b98-4b04-a4c8-873a5a187f63 35 fields · synced Oct 7, 2026
  • EUDAMED 770139a0-2a36-4c2e-a94b-ce2671d6d80f 61 fields · synced Oct 7, 2026