ShBlade Straight Ø3.5mm DS St

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name: ShBlade Straight Ø3.5mm DS St FDA UDI
Generic Name: ENT suction dissector FDA UDI
Model / Reference: 1600539 FDA UDI

Identifiers

Catalog Number: 1600539-005 FDA UDI
Primary DI / UDI-DI: 17630055505283 FDA UDI
FDA Product Code: ERL FDA UDI
NLY FDA UDI
EQJ FDA UDI
GMDN Term: ENT suction dissector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4250 FDA UDI
874.4140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ENT suction dissector

ShBlade Straight Ø3.5mm DS St by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT suction dissector.

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FENTEX — FENTEX medical GmbH · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Panetti ear drum suction dissector — Spiggle & Theis Medizintechnik GmbH · Class I
OSSEOUS Suction Tube for Sinus-Disposable — EON MEDITECH PRIVATE LIMITED · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
PILLING — TELEFLEX INCORPORATED · Class I
AESCULAP — AESCULAP, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bien-Air Surgery SA

Sources (1)

FDA UDI ae876e47-a7f1-4404-841f-35ebd480fb7d 33 fields · synced Jun 8, 2026