Identity
- Trade Name
- JOBST Elvarex Soft FDA UDI
- Generic Name
- Compression/pressure sock/stocking, reusable FDA UDI
- Device Name
- ELVAREX SOFT 3/CAPRI-BT-BODY BANDAGE/WITH SLIP FORM ON BOTH SIDES/STRAIGHT TOP, SLIP FORM WITHOUT VOLANT/BLACK FDA UDI
- Model / Reference
- 78458-00006-00 FDA UDI
- Description
- ELVAREX SOFT 3/CAPRI-BT-BODY BANDAGE/WITH SLIP FORM ON BOTH SIDES/STRAIGHT TOP, SLIP FORM WITHOUT VOLANT/BLACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04019702517255 FDA UDI
- FDA Product Code
- DWL FDA UDI
- GMDN Term
- Compression/pressure sock/stocking, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Compression/pressure sock/stocking, reusable
The JOBST Elvarex Soft compression/pressure sock/stocking is a reusable, home or clinical use device designed to provide graduated or even-force compression/pressure to treat or prevent disorders of circulation such as venous insufficiency, deep vein thrombosis (DVT), and swelling in the legs. It features an elastic material, slip-on design with slip form on both sides and straight top, and does not include antimicrobial properties.
Similar devices
Also classified as Compression/pressure sock/stocking, reusable.
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- JOBST Style — BSN MEDICAL, INC. · Class II
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- RODILLERA NEOPRENO XL NEGRO BIOFIX SPORT — TEJIDOS ELÁSTICOS LLOVERAS, S.A. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bsn-Jobst, Inc.
Sources (1)
- FDA UDI b86a8b8e-72f4-45d0-95e2-466b39863ce6 35 fields · synced Jul 8, 2026