Primary Device ID | 00858688006049 |
NIH Device Record Key | 9b7c2849-8c5c-499c-8b3e-422fe474b6bc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flex Gar Sleeve |
Version Model Number | SLEE0001 |
Company DUNS | 932471881 |
Company Name | Emsi |
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 | false |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858688006049 [Primary] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-05 |
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00859718007081 - Electrode 4.0 x 7.0- Dispersive | 2023-09-28 |
00859718007098 - Electrode 1 Inch Round 4 PK | 2023-09-28 |
00859718007104 - Electrode 2" round 4pk | 2023-09-28 |
00859718007111 - Electrode 3 Inch Round 4PK | 2023-09-28 |
00859718007135 - Electrode 2 x 4 Inch Rectangle | 2023-09-28 |