Identity
- Trade Name
- AeroWrap Thigh Small Right FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein. FDA UDI
- Model / Reference
- TW6150-03 FDA UDI
- Description
- The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein. FDA UDI
Identifiers
- Catalog Number
- TWSR FDA UDI
- Primary DI / UDI-DI
- 00856525007211 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- Compression/pressure tubular garment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Compression/pressure tubular garment
AeroWrap Thigh Small Right by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure tubular garment.
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Optiform Flex — SIGVARIS, INC. · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · 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
- Sun-Scientific Inc.
Sources (1)
- FDA UDI 76862d72-2a90-44d4-8bd2-acb567417c75 36 fields · synced Jun 6, 2026