Diamatrix

FDA UDI

Class I (US FDA UDI)

by Diamatrix

Identity

Trade Name: Diamatrix FDA UDI
Generic Name: Suturing needle holder, single-use FDA UDI
Device Name: Barraquer Needle Holder, Standard, Straight shaft 10mm smooth jaws, Without Lock, Diamond knurled handle, 135mm total length, Stainless Steel FDA UDI
Model / Reference: N14-S FDA UDI
Description: Barraquer Needle Holder, Standard, Straight shaft 10mm smooth jaws, Without Lock, Diamond knurled handle, 135mm total length, Stainless Steel FDA UDI

Identifiers

Catalog Number: N14-S FDA UDI
Primary DI / UDI-DI: 00813059016560 FDA UDI
FDA Product Code: HNR FDA UDI
GMDN Term: Suturing needle holder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, single-use

Diamatrix by Diamatrix — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Diamatrix

Sources (1)

FDA UDI ae195bca-e23c-499d-9a73-67fdbd786233 34 fields · synced Jun 8, 2026