| Primary Device ID | 00850055427044 |
| NIH Device Record Key | d9ff43d4-7352-4e02-8cce-3bff30b37801 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithotomy Drape |
| Version Model Number | FG351101 |
| Catalog Number | 351101 |
| Company DUNS | 016646472 |
| Company Name | PROCEPT BIOROBOTICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850055427044 [Primary] |
| GS1 | 10850055427041 [Package] Package: Shipper Box [8 Units] In Commercial Distribution |
| EYY | Drape, urological, disposable |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
[00850055427044]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-25 |
| Device Publish Date | 2023-12-15 |
| B6143511011 | The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barri |
| 10860009122939 | FG351101 |
| 00850055427044 | FG351101 |