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Biopsy Starter Kit

FDA UDI

by Protek Medical Products, Inc.

Identity

Trade Name
Biopsy Starter Kit FDA UDI
Generic Name
Ultrasound imaging system tracking positioner, reusable FDA UDI
Device Name
Biopsy Starter Kit for GE 4C, 4C-A, 4C-D, 4C-RS, 4C-SC & 5CS Ultrasound Transducers FDA UDI
Model / Reference
7311 FDA UDI
Description
Biopsy Starter Kit for GE 4C, 4C-A, 4C-D, 4C-RS, 4C-SC & 5CS Ultrasound Transducers FDA UDI

Identifiers

Primary DI / UDI-DI
00841912106561 FDA UDI
GMDN Term
Ultrasound imaging system tracking positioner, reusable 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

No

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-useUltrasound imaging system tracking positioner, reusableBody-surface ultrasound imaging transducer cover

Biopsy Starter Kit by Protek Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

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 651268ee-179c-4f04-b0e1-4f2d3a68d7db 33 fields · synced Jun 8, 2026