Model: DEF5943
Catalog: DEF5943
DI: 06975424199385
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Gown, XX-Large, Standard, AAMI 3
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
aa69b51e-9cb0-4487-b2a9-c14e713645d3
Distribution Status:
In Commercial Distribution
DUNS Number:
014464314
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Outer Case
Item #1 - Device ID:
26975424199389
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
36
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06975424199385
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06975424199385
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35091
Name: Surgical gown, single-use
Definition:
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 single-use garment.
FDA Product Codes
FYA
Gown, Surgical