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Biopsy Starter Kit

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Biopsy Starter Kit FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (41 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CS1-4 transducer FDA UDI
Model / Reference
657-030 FDA UDI
Description
Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (41 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CS1-4 transducer FDA UDI

Identifiers

Catalog Number
657-030 FDA UDI
Primary DI / UDI-DI
00841436106139 FDA UDI
510(k) Number
K093713 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Height — 1.85 Inch FDA UDI
Length — 4.21 Inch FDA UDI

Biopsy Starter Kit by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093713 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (1)

  • FDA UDI ff00f2cb-02b3-49a6-824f-2ebfb52fd328 39 fields · synced Jun 8, 2026