Identity
- Trade Name
- TSI FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
- Device Name
- ATRAUMATIC SUCTION TUBE, 9 FR, 127 MM FDA UDI
- Model / Reference
- LS-0396 FDA UDI
- Description
- ATRAUMATIC SUCTION TUBE, 9 FR, 127 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059111637 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical/emergency suction cannula, non-illuminating, reusable
Tsi by Tedan Surgical Innovations, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- MicroFrance® — Integra Microfrance · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCANLAN® Variable Suction Rotatable Tips — SCANLAN INTERNATIONAL INC · Class I
- Fukushima Tear Drop Suction Tube Straight Malleable 10 Fr. 21 cm - 8 1/4" Ø 3.3 mm — SURTEX INSTRUMENTS LTD · Class IIa
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 779cb72d-4b89-49a4-a871-3fcc8583c8db 33 fields · synced May 31, 2026