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Endocavity Biopsy Needle Guides

FDA UDI

by Protek Medical Products, Inc.

Identity

Trade Name
Endocavity Biopsy Needle Guides FDA UDI
Generic Name
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Device Name
Endocavity Biopsy Starter Kit for GE E8C/E8C-RS/E72/E721/MTZ/MZ/IC5-9H Ultrasound Trasnducers FDA UDI
Model / Reference
7050 FDA UDI
Description
Endocavity Biopsy Starter Kit for GE E8C/E8C-RS/E72/E721/MTZ/MZ/IC5-9H Ultrasound Trasnducers FDA UDI

Identifiers

Primary DI / UDI-DI
00841912104123 FDA UDI
GMDN Term
Body-orifice ultrasound imaging transducer cover, basic FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
Sterilization Method
High-level Disinfectant FDA UDI

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

Endocavity Biopsy Needle Guides by Protek Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Protek Medical Products, Inc.

Sources (1)

  • FDA UDI 326de1e8-4b07-4cf4-8e96-ee27b3b7b9f6 34 fields · synced May 30, 2026