Identity
- Trade Name
- SUPER SHEATH FDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- (8"-10") Royal Nylon Sheaths Regular White X-Small/Small No Hole FDA UDI
- Model / Reference
- RNS-B/0-10 FDA UDI
- Description
- (8"-10") Royal Nylon Sheaths Regular White X-Small/Small No Hole FDA UDI
Identifiers
- Catalog Number
- RNS-B/0-10 FDA UDI
- Primary DI / UDI-DI
- G296RNSB0100 FDA UDI
- FDA Product Code
- FQL FDA UDI
- GMDN Term
- Stump sock 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: Stump sock
Super Sheath by Royal Knit, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stump sock.
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- ROYAL STRETCH — Royal Knit, Inc. · Class I
- ROYAL FLUSH — Royal Knit, Inc. · Class I
- ROYAL FLUSH — Royal Knit, Inc. · Class I
- SUPER SHEATH — Royal Knit, Inc. · Class I
- ROYAL FLUSH — Royal Knit, Inc. · Class I
- ROYAL FLUSH — Royal Knit, Inc. · 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 |
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Manufacturer
- Manufacturer
- Royal Knit, Inc.
Sources (1)
- FDA UDI 6bc7f445-a15e-4d6f-b5a5-7587943a8503 34 fields · synced Jun 1, 2026