Primary Device ID | 10860009122939 |
NIH Device Record Key | cf470c15-abb7-44ba-b91a-74adaabd7755 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lithotomy Drape |
Version Model Number | FG351101 |
Catalog Number | FG351101 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860009122932 [Primary] |
GS1 | 10860009122939 [Package] Contains: 00860009122932 Package: Shipper Box [8 Units] In Commercial Distribution |
HIBCC | B6143511011 [Previous] |
EYY | Drape, urological, disposable |
Steralize Prior To Use | true |
Device Is Sterile | true |
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
[10860009122939]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-13 |
Device Publish Date | 2023-04-05 |
B6143511011 | The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barri |
10860009122939 | FG351101 |
00850055427044 | FG351101 |