Identity
- Trade Name
- Compression Stocking FDA UDI
- Generic Name
- Compression/pressure glove FDA UDI
- Device Name
- Glove to Wrist FDA UDI
- Model / Reference
- 401 FDA UDI
- Description
- Glove to Wrist FDA UDI
Identifiers
- Catalog Number
- 401 FDA UDI
- Primary DI / UDI-DI
- G420401 FDA UDI
- 510(k) Number
- K823737 FDA UDI
- FDA Product Code
- FQL FDA UDIDWL FDA UDI
- GMDN Term
- Compression/pressure glove 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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 glove
Compression Stocking by Gottfried Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Compression/pressure glove.
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- Juzo Soft — JULIUS ZORN, INC. · Class I
- Juzo Soft Seamless — JULIUS ZORN, INC. · Class I
- Juzo Soft — JULIUS ZORN, INC. · Class I
- Juzo Custom Compression Garments — JULIUS ZORN, INC. · Class I
- Juzo Soft Seamless — JULIUS ZORN, INC. · Class I
- Juzo Dynamic — JULIUS ZORN, INC. · Class I
Cleared under the same submission
K823737 also covers:
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
- Compression Stocking — GOTTFRIED MEDICAL, INC.
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
- Gottfried Medical, Inc.
Sources (1)
- FDA UDI f77585da-26f3-4973-b394-179d871f0fa0 35 fields · synced May 30, 2026