FDA UDI Not in Commercial Distribution 🇺🇸 United States

579 Melany Donning & Doffing MEDIUM

DI: 07613378105333 · Model: 309388 · SIGVARIS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
579 Melany Donning & Doffing MEDIUM
Primary DI
07613378105333
Version / Model
309388
Catalog Number
579MMD
Company Name
SIGVARIS INC
Labeler DUNS
189738719
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-27
Public Version
2
Public Version Date
2026-01-12
Public Version Status
Update
Public Device Record Key
dbe1fbf1-8e8e-497a-a77d-7c5255351fb7
Distribution End Date
2026-01-09

Device Description

A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IKX Aid, Transfer

GMDN Terms

Code Name
31050 Assistive sock/pantyhose dressing device

Identifiers

Type ID
Primary 07613378105333

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify No Device Sizes