| Primary Device ID | 10853863007344 |
| NIH Device Record Key | 08679778-12b0-4ae6-a4d3-fdd859756a87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Professional Surgical Instruments Co., Inc. |
| Version Model Number | S14-207 |
| Company DUNS | 197354343 |
| Company Name | Professional Surgical Instruments Co., Inc. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853863007347 [Primary] |
| GS1 | 10853863007344 [Package] Contains: 00853863007347 Package: [500 Units] In Commercial Distribution |
| FHQ | Holder, Needle, Gastroenterologic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
[10853863007344]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-25 |
| Device Publish Date | 2025-04-17 |
| 00853863007118 | 4.5" Straight Iris Scissors, Satin with Tip Protector |
| 10853863007344 | 5" Webster Needle Holder, Satin |
| 00810097679993 | 4.5" Iris Scissors Straight, Satin, w/ Point Protector, 4.75" Adson Tissue, Satin, & 5" Mosquito |
| 10810097679969 | 4.5" Iris Straight, Satin, w/PP and 4.5" Adson Serrated w/Point Protector |