Primary Device ID | 10850055427096 |
NIH Device Record Key | f7838e27-dab1-4837-8f1a-67bec6a0fe16 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Essential Drape 1PK |
Version Model Number | DR2500 |
Catalog Number | DR2500 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850055427099 [Primary] |
GS1 | 10850055427096 [Package] Contains: 00850055427099 Package: Shipper Box [5 Units] In Commercial Distribution |
EYY | Drape, urological, disposable |
Steralize Prior To Use | true |
Device Is Sterile | true |
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
[10850055427096]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-21 |
Device Publish Date | 2025-03-13 |
10850055427096 - Essential Drape 1PK | 2025-03-21 |
10850055427096 - Essential Drape 1PK | 2025-03-21 |
00850055427051 - HYDROS Handpiece | 2024-09-16 |
00850055427068 - HYDROS Robotic System | 2024-09-16 |
00850055427075 - HYDROS TRUS Probe | 2024-09-16 |
00850055427037 - AquaBeam Handpiece | 2023-12-25 |
00850055427044 - Lithotomy Drape | 2023-12-25 |
00850055427006 - AquaBeam Handpiece | 2023-09-04 |
00850055427013 - AquaBeam Scope | 2023-09-04 |