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CIV-Flex™ Guide Sheath

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
CIV-Flex™ Guide Sheath FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
SCOUT Guide Sheath for use with SCOUT Surgical Guidance System FDA UDI
Model / Reference
SH-01 FDA UDI
Description
SCOUT Guide Sheath for use with SCOUT Surgical Guidance System FDA UDI

Identifiers

Catalog Number
SH-01 FDA UDI
Primary DI / UDI-DI
10841436120958 FDA UDI
510(k) Number
K970513 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Width — 8.3 Centimeter FDA UDI
Length — 264 Centimeter FDA UDI

Category: Body-surface ultrasound imaging transducer cover

CIV-Flex™ Guide Sheath by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K970513 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 9e13cff3-41e7-4596-8705-8416e266ecdc 38 fields · synced Jun 8, 2026