DEVICE: ComPel MLR Surgical Gown (00634916496949)
Device Identifier (DI) Information
ComPel MLR Surgical Gown
75673627
Not in Commercial Distribution
75673627
STANDARD TEXTILE CO., INC.
75673627
Not in Commercial Distribution
75673627
STANDARD TEXTILE CO., INC.
ComPel MLR Backless Pathology Gown 1-Ply Front, 2-Ply sleeves, size Small
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11902 | Surgical gown, reusable |
A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment intended to be laundered after each use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FYA | Gown, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041541 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4d70eab5-7e47-4277-804c-5d74b2f91d16
July 03, 2023
5
April 03, 2020
July 03, 2023
5
April 03, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10634916496946
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-999-0400
GUDID@standardtextile.com
GUDID@standardtextile.com