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HS-Handpiece, angled, 95mm, 80k

FDA UDI

Class I (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
HS-Handpiece,angled,95mm,80k FDA UDI
Generic Name
Drilling power tool attachment, basic FDA UDI
Model / Reference
362682 FDA UDI

Identifiers

Catalog Number
1601107-001 FDA UDI
Primary DI / UDI-DI
07630055506405 FDA UDI
FDA Product Code
NLY FDA UDI
ERL FDA UDI
EQJ FDA UDI
HBE FDA UDI
HBC FDA UDI
GMDN Term
Drilling power tool attachment, basic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4140 FDA UDI
874.4250 FDA UDI
882.4310 FDA UDI
882.4360 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: Drilling power tool attachment, basic

HS-Handpiece, angled, 95mm, 80k by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drilling power tool attachment, basic.

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 b1d9b229-88e1-4250-8a08-97b2fb33a624 33 fields · synced Jun 8, 2026