Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name: ASSI FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Collier Ndl. Hdl. 12cm W/ Fenestrated Jaw W/ Longitudinal Serration FDA UDI
Model / Reference: ASSI.ATK24326 FDA UDI
Description: Collier Ndl. Hdl. 12cm W/ Fenestrated Jaw W/ Longitudinal Serration FDA UDI

Identifiers

Primary DI / UDI-DI: 00841645106876 FDA UDI
FDA Product Code: FHQ FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 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

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

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Suturing needle holder, reusable

Assi by Accurate Surgical & Scientific Instruments Corp. — 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: Accurate Surgical & Scientific Instruments Corp.

Sources (1)

FDA UDI 812d0511-f90a-4df5-a27f-7314a194012c 33 fields · synced May 30, 2026