Primary Device ID | 00841277101317 |
NIH Device Record Key | 8e10072f-377b-4047-aebf-c892a1ee66c0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SemperSure Nitrile Exam Glove |
Version Model Number | SUNF204 |
Catalog Number | SUNF204 |
Company DUNS | 004072158 |
Company Name | SEMPERMED USA, INC. |
Device Count | 200 |
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 | false |
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 | false |
OTC Over-The-Counter | true |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841277101317 [Primary] |
GS1 | 00841277103533 [Unit of Use] |
OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-09 |
Device Publish Date | 2020-01-01 |
00841277101331 | SemperSure Nitrile Exam Glove, sample pack |
00841277101324 | SemperSure Nitrile Exam Glove, size XL |
00841277101317 | SemperSure Nitrile Exam Glove, size L |
00841277101300 | SemperSure Nitrile Exam Glove, size M |
00841277101294 | SemperSure Nitrile Exam Glove, size S |
00841277101287 | SemperSure Nitrile Exam Glove, size XS |