Identity
- Trade Name
- TSI FDA UDI
- Generic Name
- Brain spatula FDA UDI
- Device Name
- CONCAVE SPATULA, 45 MM, 16 MM, SST FDA UDI
- Model / Reference
- TK-1234 FDA UDI
- Description
- CONCAVE SPATULA, 45 MM, 16 MM, SST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851797006689 FDA UDI
- 510(k) Number
- K161318 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Brain spatula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 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
No
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: Brain spatula
Tsi by Tedan Surgical Innovations, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brain spatula.
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Sklar — Sklar Corporation · Class I
- LAZIC — Peter Lazic GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Sklar — Sklar Corporation · Class I
- LAZIC — Peter Lazic GmbH · Class I
Cleared under the same submission
K161318 also covers:
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C.
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
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 8fd2755a-d88b-426c-b027-7173ea9a4775 34 fields · synced Jun 1, 2026