| Primary Device ID | 00811714036342 |
| NIH Device Record Key | 9959270d-f352-494b-8ce5-164154b180ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Agile Instruments |
| Version Model Number | 285946 |
| Catalog Number | 285946 |
| Company DUNS | 002745858 |
| Company Name | RESPONSIVE ORTHOPEDICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811714036342 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-08 |
| Device Publish Date | 2025-03-31 |
| 00811714036335 - Agile Suture Anchor | 2025-04-08 Agile Suture Anchor, 2.5mm diameter with one #2 HS Fiber Suture |
| 00811714036342 - Agile Instruments | 2025-04-08Drill (2.0mm), Drill Guide, and 2 Free Needles |
| 00811714036342 - Agile Instruments | 2025-04-08 Drill (2.0mm), Drill Guide, and 2 Free Needles |
| 00811714036106 - Lightning Long | 2024-05-28 Lightning Guide Tube Castle Long |
| 00811714036113 - Lightning Long | 2024-05-28 Lightning Long V-Mouth Guide Tube |
| 00811714036120 - Lightning | 2024-05-28 Lightning Blunt Probe |
| 00811714035994 - Stealth | 2024-04-09 Stealth Drill 3.0mm |
| 00811714036007 - Stealth | 2024-04-09 Stealth Castle Guide Tube |
| 00811714036014 - Stealth | 2024-04-09 Stealth Soft Bone Drill 3.0mm |