Primary Device ID | 10194422075535 |
NIH Device Record Key | 32922eb4-89f5-4fcf-9948-1fe38dd84264 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FRUIT HEALTH |
Version Model Number | PI.408EGHT.O6J.2X.0.0 |
Company DUNS | 110555005 |
Company Name | Fruit of the Loom |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
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 | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM | |
Phone | 1-800-551-7625 |
FDA@FOTLINC.COM |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00194422075538 [Primary] |
GS1 | 10194422075535 [Package] Contains: 00194422075538 Package: POLY BAG [10 Units] In Commercial Distribution |
GS1 | 20194422075532 [Package] Package: CARTON [10 Units] In Commercial Distribution |
OEA | Non-Surgical Isolation Gown |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-21 |
Device Publish Date | 2022-03-11 |
10194422075542 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC |
10194422075535 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC |
10194422075528 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC |
10194422108271 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC |
10194422108264 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGI |
10194422108257 | 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC |