Identity
- Trade Name
- EIT TLIF Instrument Tray FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- TLIF instrument tray FDA UDI
- Model / Reference
- TEC00100 FDA UDI
- Description
- TLIF instrument tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260397081297 FDA UDI
- 510(k) Number
- K170503 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Device sterilization/disinfection container, 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
EIT TLIF Instrument Tray by EIT Emerging Implant Technologies GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170503 also covers:
- EIT ALIF Paddle Distractor — EIT Emerging Implant Technologies GmbH
- EIT ALIF Paddle Distractor — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
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
- EIT Emerging Implant Technologies GmbH
Sources (1)
- FDA UDI b20299b2-1bc8-4bc1-a907-cfd68133e79b 34 fields · synced Jun 6, 2026