Primary Device ID | 20847212008424 |
NIH Device Record Key | 19522d95-f927-4998-a36b-80bc2f1b9e27 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Elara Brands |
Version Model Number | MN103BK |
Company DUNS | 010850179 |
Company Name | Elara Foodservice Disposables LLC |
Device Count | 100 |
DM Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847212008420 [Primary] |
GS1 | 20847212008424 [Unit of Use] |
LZA | Polymer Patient Examination Glove |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-13 |
Device Publish Date | 2024-02-05 |
20847212008431 | Nitrile Examination Gloves, Black, 3 Gram, Size XL |
20847212008424 | Nitrile Examination Gloves, Black, 3 Gram, Size Large |
20847212008417 | Nitrile Examination gloves, Black, 3 Gram, size medium |
20847212008400 | Nitrile Examination Gloves, Black, 3 Gram, size small |
20847212008394 | Nitrile Examination Gloves, Blue, 3 Gram, Size XL |
20847212008387 | Nitrile Examination Gloves, 3 Gram, Blue, Size L |
20847212007939 | Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size x-large |
20847212007922 | Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size large |
20847212007915 | Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size medium |
20847212007908 | Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size small |