Identity
- Trade Name
- ShBlade Straight Ø2.1mm DS St FDA UDI
- Generic Name
- ENT suction dissector FDA UDI
- Model / Reference
- 1601070 FDA UDI
Identifiers
- Catalog Number
- 1601070-001 FDA UDI
- Primary DI / UDI-DI
- 17630055509878 FDA UDI
- FDA Product Code
- EQJ FDA UDI
- GMDN Term
- ENT suction dissector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENT suction dissector
ShBlade Straight Ø2.1mm DS St by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT suction dissector.
- Adler Instrument Company — Adler, Inc. · Class I
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 37b68f93-fb6a-4b9c-a129-9ad9b70ec7bd 33 fields · synced May 30, 2026