Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name: ASSI FDA UDI
Generic Name: Surgical instrument/implant rack FDA UDI
Device Name: Barraquer Ndl Hdl, 15cm, Rnd Hdl. 8mm dia, Del. Cvd Jaw 0.4mm dia., w/o lock FDA UDI
Model / Reference: ASSI.80019 FDA UDI
Description: Barraquer Ndl Hdl, 15cm, Rnd Hdl. 8mm dia, Del. Cvd Jaw 0.4mm dia., w/o lock FDA UDI

Identifiers

Primary DI / UDI-DI: 00841645109167 FDA UDI
FDA Product Code: HXK FDA UDI
GMDN Term: Surgical instrument/implant rack FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Category: Surgical instrument/implant rack

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 9448ed1b-831c-483f-ad09-b939dd1911b5 33 fields · synced May 30, 2026