Primary Device ID | 00869653000214 |
NIH Device Record Key | 0f611e61-5989-4a22-b7be-8a2b130abd7e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dinamic OR Spine Rack Monitor Cover 60x64cm |
Version Model Number | Gerstner-Moncover-01A |
Catalog Number | Gerstner-Moncover-01A |
Company DUNS | 080180725 |
Company Name | FLEX OPERATING ROOM, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 585-635-7260 |
greg@gerstnermedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00869653000207 [Primary] |
GS1 | 00869653000214 [Package] Contains: 00869653000207 Package: Case [100 Units] In Commercial Distribution |
KKX | Drape, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-20 |
06975424191761 - Flex Operating Room, LLC | 2023-04-07 Double Wide A-Rack |
06975424191778 - Flex Operating Room, LLC | 2023-04-07 Triple Wide Rack |
10869653000228 - Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 | 2018-12-10 |
10869653000235 - Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 | 2018-12-10 |
10869653000242 - Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 | 2018-12-10 |
00869653000214 - Dinamic OR Spine Rack Monitor Cover 60x64cm | 2018-03-29 |
00869653000214 - Dinamic OR Spine Rack Monitor Cover 60x64cm | 2018-03-29 |