← Back to catalogue

Needle Guide

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Needle Guide FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Sterile needle guides (.5cm, 1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex™ cover for use with SonoSite FDA UDI
Model / Reference
610-1246, 610-1246-5 FDA UDI
Description
Sterile needle guides (.5cm, 1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex™ cover for use with SonoSite FDA UDI

Identifiers

Catalog Number
610-1246, 610-1246-5 FDA UDI
Primary DI / UDI-DI
10841436102787 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

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
Length — 2.9 Inch FDA UDI
Width — 2.6 Inch FDA UDI

Needle Guide 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (1)

  • FDA UDI 92d1072d-46c1-414d-9947-c92589c02794 39 fields · synced Jun 8, 2026