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Cranio Guard 10mm rotating

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
Cranio Guard 10mm rotating FDA UDI
Generic Name
Trephining power tool attachment FDA UDI
Model / Reference
1600880 FDA UDI

Identifiers

Catalog Number
1600880-001 FDA UDI
Primary DI / UDI-DI
07630055505811 FDA UDI
FDA Product Code
HBC FDA UDI
HBE FDA UDI
GMDN Term
Trephining power tool attachment FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4360 FDA UDI
882.4310 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

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Trephining power tool attachment

Cranio Guard 10mm rotating by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trephining power tool attachment.

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 e9c8eeaf-18b0-40c0-8952-3030be4abf6d 33 fields · synced May 31, 2026