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Insurgical, Inc.

FDA UDI

Class I (US FDA UDI)

by Insurgical, Inc.

Identity

Trade Name
Insurgical, Inc. FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, single-use FDA UDI
Device Name
Oscillating Saw Packaged Assembly FDA UDI
Model / Reference
320-0067-001 FDA UDI
Description
Oscillating Saw Packaged Assembly FDA UDI

Identifiers

Catalog Number
3010002 FDA UDI
Primary DI / UDI-DI
00860007230035 FDA UDI
FDA Product Code
KIJ FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, electric, single-use

Insurgical, Inc. by Insurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insurgical, Inc.

Sources (1)

  • FDA UDI 06ff6eca-5578-46ea-a3aa-74003afd15db 34 fields · synced May 30, 2026