Identity
- Trade Name
- Sklar FDA UDI
- Generic Name
- Headband, reusable FDA UDI
- Device Name
- SKLAR POLYETHYLENE HEADBAND FDA UDI
- Model / Reference
- 73-1082 FDA UDI
- Description
- SKLAR POLYETHYLENE HEADBAND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111325281 FDA UDI
- FDA Product Code
- HKF FDA UDI
- GMDN Term
- Headband, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1500 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Headband, reusable
Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Headband, reusable.
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- Fiberoptics Technology Inc — FIBEROPTICS TECHNOLOGY, INC. · Class II
- MEZUT — Shanghai Jianying Medical Technology Co., Ltd. · Class I
- Enova Illumination — ENOVA ILLUMINATION, INC · Class I
- Sklar — Sklar Corporation · Class I
- Sklar — Sklar Corporation · 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
- Sklar Corporation
Sources (1)
- FDA UDI 516f19a5-83b9-4ab3-9563-23d827f1b506 33 fields · synced May 30, 2026