PinPoint

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: PinPoint FDA UDI
Generic Name: Skin topical coupling gel FDA UDI
Device Name: PinPnt Gelcap w/ndleguid, .25-.75cm20-22Ga.50Proc FDA UDI
Model / Reference: 9A10111 FDA UDI
Description: PinPnt Gelcap w/ndleguid, .25-.75cm20-22Ga.50Proc FDA UDI

Identifiers

Catalog Number: 9A10111 FDA UDI
Primary DI / UDI-DI: 00801741091216 FDA UDI
FDA Product Code: ITX FDA UDI
MUI FDA UDI
GMDN Term: Skin topical coupling gel 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Depth — 0.5 Centimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI
Needle Gauge — 22 Gauge FDA UDI
Depth — 0.75 Centimeter FDA UDI
Depth — 0.25 Centimeter FDA UDI

Category: Skin topical coupling gel

PinPoint by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI c7ca6711-8196-44a3-9f7c-b53d4d23829e 37 fields · synced Jun 9, 2026