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OSSEODOC Control Unit + Pump

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
OSSEODOC Control Unit + Pump FDA UDI
Generic Name
Surgical power tool system control unit, line-powered FDA UDI
Model / Reference
1600331 FDA UDI

Identifiers

Catalog Number
1600331-001 FDA UDI
Primary DI / UDI-DI
J00716003310011 FDA UDI
510(k) Number
K792159 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Surgical power tool system control unit, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

OSSEODOC Control Unit + Pump by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K792159 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bien-Air Surgery SA

Sources (1)

  • FDA UDI ad269f0c-7422-499b-9628-ca40ef2d7331 35 fields · synced May 31, 2026