Primary Device ID | 00854150007125 |
NIH Device Record Key | f3a6d533-f5b2-4e3a-b5d7-e5f794b2b721 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DS-100 ORI Drop Stop Kit |
Version Model Number | DS-100 |
Catalog Number | DS-100 |
Company DUNS | 080246656 |
Company Name | OPERATING ROOM INNOVATIONS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854150007118 [Primary] |
GS1 | 00854150007125 [Package] Contains: 00854150007118 Package: Case [40 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 | 3 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2017-03-02 |
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16975085709418 - ORI | 2023-04-12 HaloFit XXX-Large with Face Shield AAMI IV |
26975424191451 - ORI | 2023-04-12 Face Shield, Attached with Full Head Covering |
26975424191468 - ORI | 2023-04-12 ORI Drop Stop |
26975424191475 - ORI | 2023-04-12 Face Shield, Attached w. AAMI IV Head Covering |
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26975085708524 - ORI | 2023-04-11 SterileBack Toga XL-EL w. Face Shield |