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Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name
ASSI FDA UDI
Generic Name
Orthopaedic osteotome FDA UDI
Device Name
Osteotome 16cm, 6mm, solid octangular handle FDA UDI
Model / Reference
ASSI.ATK22926 FDA UDI
Description
Osteotome 16cm, 6mm, solid octangular handle FDA UDI

Identifiers

Primary DI / UDI-DI
00841645130246 FDA UDI
FDA Product Code
HWM FDA UDI
GMDN Term
Orthopaedic osteotome 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome

Assi by Accurate Surgical & Scientific Instruments Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic osteotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accurate Surgical & Scientific Instruments Corp.

Sources (1)

  • FDA UDI 5478afc0-4ca0-4fe4-8f31-a9f49d449196 33 fields · synced Jun 1, 2026