Model: 230
Catalog: 230
DI: 00850011216309
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Distribution End: 2030-11-30
Description
Mammography Top
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bca02199-7e6b-4510-9536-3497ad5d5804
Distribution Status:
In Commercial Distribution
DUNS Number:
040942451
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850011216309
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 11905
Name: Patient gown, reusable
Definition:
A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.
FDA Product Codes
FME
Gown, Examination