| Primary Device ID | 13661234017437 |
| NIH Device Record Key | 7fcf09f3-9b58-4289-aa48-092077cbe4d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFLATION SYSTEM |
| Version Model Number | 03.804.413S |
| Company DUNS | 267476323 |
| Company Name | PEROUSE MEDICAL |
| 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 | false |
| 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 | 03661234017430 [Primary] |
| GS1 | 13661234017437 [Package] Contains: 03661234017430 Package: [1 Units] In Commercial Distribution |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2017-04-12 |
| 33661234025207 - PEROUSE MEDICAL | 2024-04-17 NEEDLE GUIDE Ø1,2MM |
| 43661234025198 - PEROUSE MEDICAL | 2024-04-03 NEEDLE GUIDE Ø1,0MM |
| 43661234025235 - PEROUSE MEDICAL | 2024-04-03 NEEDLE GUIDE Ø0,9MM |
| 33661234025184 - PEROUSE MEDICAL | 2024-03-28 NEEDLE GUIDE Ø0,9MM |
| 43661234025228 - PEROUSE MEDICAL | 2024-03-28 NEEDLE GUIDE Ø1,8MM |
| 33661234025245 - PEROUSE MEDICAL | 2024-03-28 NEEDLE GUIDE Ø1,0MM |
| 33661234025252 - PEROUSE MEDICAL | 2024-03-22 NEEDLE GUIDE Ø1,2MM |
| 33661234025269 - PEROUSE MEDICAL | 2024-03-22 NEEDLE GUIDE Ø2,25MM |