| Primary Device ID | 00810007560021 |
| NIH Device Record Key | 42e04844-4870-4db7-a0b2-8fd5c151de42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPY-PHI System |
| Version Model Number | HH1003 |
| Company DUNS | 968677414 |
| Company Name | AXCESS SURGICAL INNOVATIONS, LLC |
| 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 | true |
| 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 | 00810007560021 [Primary] |
| FXR | Holder, Camera, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
[00810007560021]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-06 |
| Device Publish Date | 2019-08-29 |
| 00810007560021 | SPY-PHI Articulating Arm, Imaging Head Holder |
| 00810007560014 | SPY-PHI Articulating Arm, Table Clamp |
| 00810007560007 | SPY-PHI Articulating Arm, Main Arm |