J-Needle

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: J-Needle FDA UDI
Generic Name: Suturing needle, reusable FDA UDI
Device Name: J-Needle Suturing Needle; obese patient FDA UDI
Model / Reference: 5002 FDA UDI
Description: J-Needle Suturing Needle; obese patient FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937019810 FDA UDI
FDA Product Code: GAB FDA UDI
GMDN Term: Suturing needle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 17.5 Centimeter FDA UDI
Tip Bend Radius — 0.9 Centimeter FDA UDI
Length — 6.5 Centimeter FDA UDI

Category: Suturing needle, reusable

J-Needle by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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Hurd tonsil suture needle, right, 22 cm — Spiggle & Theis Medizintechnik GmbH · Class I

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 I	Pending data

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI ccb25856-ce76-4cee-9ce6-0033d4f7e459 34 fields · synced Jun 9, 2026