Identity
- Trade Name
- Delivery Tip FDA UDI
- Generic Name
- Nerve cap delivery mixer/needle FDA UDI
- Device Name
- The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use. FDA UDI
- Model / Reference
- TL-7627 FDA UDI
- Description
- The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use. FDA UDI
Identifiers
- Catalog Number
- TL-7627 FDA UDI
- Primary DI / UDI-DI
- 00860012518128 FDA UDI
- 510(k) Number
- DEN230061 FDA UDI
- FDA Product Code
- SBG FDA UDI
- GMDN Term
- Nerve cap delivery mixer/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5260 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nerve cap delivery mixer/needle
Delivery Tip by Tulavi Therapeutics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
DEN230061 also covers:
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
- Tulavi Therapeutics
Sources (1)
- FDA UDI 50432dc8-e328-4adc-aee8-d369fb02a692 36 fields · synced Jun 7, 2026