Primary Device ID | 00849554007116 |
NIH Device Record Key | f617802b-6808-41ec-bee3-428e719f6cf4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PREVENA RESTOR™ ARTHRO•FORM™ |
Version Model Number | PRE5101 |
Company DUNS | 102726734 |
Company Name | KCI USA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849554007116 [Primary] |
OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-14 |
Device Publish Date | 2019-03-04 |
00849554007116 | PREVENA RESTOR™ ARTHRO•FORM™ 46CM X 30CM SYSTEM KIT |
00849554006812 | PREVENA RESTOR™ ARTHRO•FORM™ DRESSING – 33CM X 30CM |
00849554007109 | PREVENA RESTOR™ ARTHRO•FORM™ DRESSING – 46CM X 30CM |
00849554006805 | PREVENA RESTOR™ ARTHRO•FORM™ 33CM X 30CM SYSTEM KIT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PREVENA RESTOR 88099676 not registered Live/Pending |
KCI LICENSING, INC. 2018-08-30 |