Primary Device ID | 00634916394535 |
NIH Device Record Key | 8f9329c2-587d-4dd1-8cce-33e644f7fc8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MAMMOGRAPHY GOWN |
Version Model Number | 74296789 |
Catalog Number | 74296789 |
Company DUNS | 006999858 |
Company Name | STANDARD TEXTILE CO., INC. |
Device Count | 48 |
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 | 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 | true |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com | |
Phone | 1-800-999-0400 |
GUDID@standardtextile.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00634916394535 [Primary] |
GS1 | 10634916394535 [Unit of Use] |
FME | Gown, Examination |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-06-21 |
Device Publish Date | 2018-05-21 |
00634916457667 | Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, singl |
00634916457643 | Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, singl |
00634916394535 | MAMMOGRAPHY GOWN, 100% Polyester, Burgundy 3XL |
00634916394528 | MAMMOGRAPHY GOWN, 100% Polyester, Burgundy OSFA |