Identity
- Trade Name
- Konmed FDA UDI
- Generic Name
- Tubular support bandage, non-latex, reusable FDA UDI
- Device Name
- It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature: - The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand - The hollow designing on the heel part is good to wear - The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic - With left and right design difference - The tiptoe part can be trimmed based on your size - The “8” shape straps is detachable FDA UDI
- Model / Reference
- KM-F-58 FDA UDI
- Description
- It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature: - The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand - The hollow designing on the heel part is good to wear - The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic - With left and right design difference - The tiptoe part can be trimmed based on your size - The “8” shape straps is detachable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830505 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Tubular support bandage, non-latex, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tubular support bandage, non-latex, reusable
Konmed by Shenzhen Konmed Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Shenzhen Konmed Technology Co., Ltd.
Sources (1)
- FDA UDI 68ff0c70-6ada-4a4c-829b-68011e5646e8 33 fields · synced Jun 1, 2026