Primary Device ID | 00821925024519 |
NIH Device Record Key | 86d65472-45fc-4ab9-ab50-63ee3d7d92e7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PLAT SH CRK PSTN 1X.8X4.5 |
Version Model Number | 907011 |
Company DUNS | 007198742 |
Company Name | Gyrus Acmi, Inc. |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925024519 [Primary] |
ETB | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-04 |
00821925041394 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR |
00821925041400 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR |
00821925041417 - InstaClear | 2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR |
00821925041424 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR |
00821925041431 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR |
00821925041448 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR |
00821925041455 - InstaClear | 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR |
00810008180983 - nCare | 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG |