| Primary Device ID | D807115100011 |
| NIH Device Record Key | 0c04aabb-80c9-48f6-90c2-aae18a8fdc6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STRIPPABLE FIBER |
| Version Model Number | 115-100-01 |
| Catalog Number | 115-100-01 |
| Company DUNS | 053475903 |
| Company Name | GAC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D807115100011 [Primary] |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2017-06-26 |
| D807100141101 - IN-OVATION® C | 2020-01-31 IN-OVATION® C RT RX 018/UR4&5 -7T0A2 HK |
| D807100241101 - IN-OVATION® C | 2020-01-31 IN-OVATION® C RT RX 018/UL4&5 -7T0A2DHK |
| D807310111001 - Ovation® C | 2020-01-31 Ovation® C RT RX 018/UR1 12T 5A |
| D807310112001 - Ovation® C | 2020-01-31 Ovation® C RT RX 022/UR1 12T 5A |
| D807310121001 - Ovation® C | 2020-01-31 Ovation® C RT RX 018/UR2 8T 9A |
| D807310122001 - Ovation® C | 2020-01-31 Ovation® C RT RX 022/UR2 8T 9A |
| D807310131001 - Ovation® C | 2020-01-31 Ovation® C RT RX 018/UR3 -2T 13A 4M |
| D807310131101 - Ovation® C | 2020-01-31 Ovation® C RT RX 018/UR3-2T 13A 4M HK |