Primary Device ID | 40888937012413 |
NIH Device Record Key | 458c96cb-91a4-4496-af2c-5bdb4e9d9e90 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Galenica |
Version Model Number | 8615 |
Company DUNS | 801895244 |
Company Name | Coopersurgical, 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 | false |
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 | 00888937012415 [Primary] |
GS1 | 20888937012419 [Package] Contains: 00888937012415 Package: [50 Units] In Commercial Distribution |
GS1 | 40888937012413 [Package] Contains: 20888937012419 Package: [40 Units] In Commercial Distribution |
HIB | Speculum, Vaginal, Nonmetal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
20888937010125 | Galenica 10 Vaginal Specula • Large |
40888937010112 | Galenica 10 Vaginal Specula • Medium |
50888937010102 | Galenica 10 VAGINAL SPECULA • SMALL |
40888937012437 | Galenica 1 Large Vaginal Speculum |
40888937012420 | Galenica 1 Medium Vaginal Speculum |
40888937012413 | Galenica 1 Small Vaginal Speculum |