| Primary Device ID | 00607915117375 |
| NIH Device Record Key | b08344b9-b775-473f-aea4-2ea046a95b4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct Drive Laparoscopic Scissors System |
| Version Model Number | CB101 |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915117375 [Primary] |
| HET | Laparoscope, Gynecologic (And Accessories) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00607915117375]
Moist Heat or Steam Sterilization
[00607915117375]
Moist Heat or Steam Sterilization
[00607915117375]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2017-07-13 |
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