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Scanning Kit

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Scanning Kit FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Non-sterile scanning kit with extension tube, (60cc) syringe, 3-way stopcock, latex covers (24) and o-rings (40) FDA UDI
Model / Reference
612-056 FDA UDI
Description
Non-sterile scanning kit with extension tube, (60cc) syringe, 3-way stopcock, latex covers (24) and o-rings (40) FDA UDI

Identifiers

Catalog Number
612-056 FDA UDI
Primary DI / UDI-DI
00841436104791 FDA UDI
510(k) Number
K970515 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Body-surface ultrasound imaging transducer cover 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

Yes

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

Dimensions & Sizes

Size
Length — 6.37 Inch FDA UDI
Total Volume — 60 Milliliter FDA UDI

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

Cleared under the same submission

K970515 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 5d0c8fed-58c0-4a9f-a213-165df37dbd37 39 fields · synced Jun 8, 2026