| Primary Device ID | 00869193000071 |
| NIH Device Record Key | 7401e04a-381a-4c63-abaf-a66b50c2743f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Topica Laceration Closure Tray |
| Version Model Number | TLC 001 |
| Company DUNS | 786846571 |
| Company Name | PRECISION MEDICAL DEVICES, LLC |
| Device Count | 25 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com | |
| Phone | 3027782335 |
| wgreen@thetring.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869193000071 [Unit of Use] |
| GS1 | 00869193000088 [Primary] |
| OVN | Suture Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
[00869193000071]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-23 |
| Device Publish Date | 2025-06-14 |
| 00869193000002 - T-STRIP | 2025-06-23 The T-Strip is a 2.0 X 7.5 cm porous mesh wound closure strip that allows quick, and easy approximation of the edges of traumati |
| 00869193000071 - Topica Laceration Closure Tray | 2025-06-23The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions that would otherwise be closed with sutures. The TLC tray contains the T-RING digit tourniquet, the T-Strip wound closure mesh, topical lidocaine gel, 3" x 3" gauze, scissors and benzoin ampule. T-Strip is ideal for Topical Laceration Closure, and is designed to be used with the T-RING digit tourniquet to treat most uncomplicated finger lacerations. The T-Strip can also be used alone to treat superficial lacerations and skin avulsions that occur on other parts of the body. Using the T-Strip and a topical skin adhesive often eliminates the need for laceration trays, painful injections, and sutures; allowing most repairs to be completed in minutes. |
| 00869193000071 - Topica Laceration Closure Tray | 2025-06-23 The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions th |
| 00869193000040 - T-RING FLEX Digit Tourniquet | 2025-06-19 The T-RING FLEX is a non-pneumatic tourniquet for digits (fingers and toes). It is one size fits all, and automatically adjusts |
| 10869193000016 - T-RING Digit Tourniquet | 2025-06-18 The T-RING is a non-pneumatic tourniquet for digits (fingers and toes). It is one size fits all, and automatically adjusts to th |