Model: FC181NH3
DI: 00636257214282
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-07
Current Version: 2026-05-15
Description
!ROYFA PATTERN CALF 15-20 NAVY HEART L
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0b4d6005-5dd8-4cab-9d3e-0c3bbe8fcb25
Distribution Status:
In Commercial Distribution
DUNS Number:
960754430
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:
00636257214282
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 30878
Name: Compression/pressure sock/stocking, single-use
Definition:
A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.
FDA Product Codes
DWL
Stocking, medical support (to prevent pooling of blood in legs)