| Primary Device ID | 00844735002850 |
| NIH Device Record Key | a68f8943-1c05-4389-9798-00e91780943e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM COUPLER Forceps |
| Version Model Number | GEM4183C |
| Catalog Number | 519306001010 |
| Company DUNS | 031284586 |
| Company Name | SYNOVIS MICRO COMPANIES ALLIANCE, 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 | false |
| 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 | true |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844735002850 [Primary] |
| GS1 | 00844735006698 [Direct Marking] |
| HTD | FORCEPS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
[00844735002850]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00844735006728 - DERMACLOSE | 2024-07-05 DERMACLOSE (66CM) US-APAC |
| 00844735006735 - DERMACLOSE | 2024-07-05 DERMACLOSE (95CM) US-APAC |
| 10844735006237 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins. |
| 10844735006244 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006251 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006268 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006275 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006282 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |