Identity
- Trade Name
- ROYAL STRETCH FDA UDI
- Generic Name
- Compression/pressure sock/stocking, single-use FDA UDI
- Device Name
- (12"-14") Royal Stretch 5 Ply Wool XX-Large With Hole FDA UDI
- Model / Reference
- ORS5-4/6-14 FDA UDI
- Description
- (12"-14") Royal Stretch 5 Ply Wool XX-Large With Hole FDA UDI
Identifiers
- Catalog Number
- ORS5-4/6-14 FDA UDI
- Primary DI / UDI-DI
- G296ORS546140 FDA UDI
- FDA Product Code
- FQL FDA UDI
- GMDN Term
- Compression/pressure sock/stocking, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression/pressure sock/stocking, single-use
Royal Stretch by Royal Knit, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, single-use.
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain soft — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft S — Bauerfeind GmbH & Co. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain micro — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft, AG, Top band silicone micro dots, Ccl2, open toe, L Plus short, Cream — Bauerfeind AG · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Royal Knit, Inc.
Sources (1)
- FDA UDI 21b8e989-2fd1-4d5b-8119-b4d1eba8a2ff 34 fields · synced Jun 8, 2026