| Primary Device ID | B0995403920 |
| NIH Device Record Key | 047143c8-755f-4840-b1f8-f57fcfa7a622 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GOMCO CIRCUMCISION CLAMP |
| Version Model Number | 540-392 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 800-821-7496 |
| info@sontecinstruments.com | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com |
| Lumen/Inner Diameter | 13 Millimeter |
| Lumen/Inner Diameter | 13 Millimeter |
| Lumen/Inner Diameter | 13 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896001602 [Primary] |
| HIBCC | B0995403920 [Previous] |
| HFX | Clamp, Circumcision |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B0995403920]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B0995403920]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B0995403920]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2018-08-22 |
| B0995403960 | GOMCO CIRCUMCISION CLAMP CHROME |
| B099540394B0 | BLK GOMCO CIRCUMCISION CLAMP |
| B0995403940 | GOMCO CIRCUMCISION CLAMP CHROME |
| B099540392B0 | BLACK GOMCO CIRCUMCISION CLAMP |
| B0995403920 | GOMCO CIRCUMCISION CLAMP CHROME |
| B099540390B0 | BLACK GOMCO CIRCUMCISION CLAMP CHROME |
| B099540388B0 | BLACK GOMCO CIRCUMCISION CLAMP |
| B099540396B0 | BLACK GOMCO CIRCUMCISION CLAMP |
| B0995403890 | GOMCO CIRCUMCISION CLAMP CHROME |