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GE Reusable Endocavity Needle Guide

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
GE Reusable Endocavity Needle Guide FDA UDI
Generic Name
Needle guide, reusable FDA UDI
Device Name
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers FDA UDI
Model / Reference
H48701MM FDA UDI
Description
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers FDA UDI

Identifiers

Catalog Number
H48701MM FDA UDI
Primary DI / UDI-DI
00841436110570 FDA UDI
510(k) Number
K875128 FDA UDI
K875240 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Needle guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 7.1 Inch FDA UDI
Width — 1.1 Inch FDA UDI

GE Reusable Endocavity 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

K875128 also covers:

K875240 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 77366dc6-854c-4bc8-867b-290fe4d7abf8 38 fields · synced Jun 8, 2026