Identity
- Trade Name
- TSI FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
- Device Name
- MALLEABLE TAPERED SUCTION, 10 FR, 120 MM FDA UDI
- Model / Reference
- TK-1104 FDA UDI
- Description
- MALLEABLE TAPERED SUCTION, 10 FR, 120 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059115901 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.
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- 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 |
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Manufacturer
- Manufacturer
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 14085736-d62e-407e-9fee-d962446a596f 33 fields · synced May 30, 2026