FDA UDI
In Commercial Distribution
🇺🇸 United States
Delivery Tip
DI: 00860012518128
·
Model: TL-7627
·
Tulavi Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Delivery Tip
- Primary DI
- 00860012518128
- Version / Model
- TL-7627
- Catalog Number
- TL-7627
- Company Name
- Tulavi Therapeutics, Inc.
- Labeler DUNS
- 102780142
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-20
- Public Version
- 2
- Public Version Date
- 2025-11-19
- Public Version Status
- Update
- Public Device Record Key
- 50432dc8-e328-4adc-aee8-d369fb02a692
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SBG | In Situ Polymerizing Peripheral Nerve Cap | Neurology | 882.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67326 | Nerve cap delivery mixer/needle | A surgical device consisting of a fluid mixer and blunt needle intended to be attached to a dual-barrel syringe containing fluid preparation components of an implantable nerve cap agent, to mix the components and deliver the agent to the end of an amputated peripheral nerve for capping (shielding) during surgery. The nerve cap agent is intended to create physical barrier to reduce the risk of symptomatic neuroma; the syringe and nerve cap materials are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860012518125 | GS1 | Shelf Carton | 6 | In Commercial Distribution | |
| Primary | 00860012518128 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius