Identity
- Trade Name
- JEDMED FDA UDI
- Generic Name
- Loupe FDA UDI
- Device Name
- BATTERY PACK LITH/ION FS 6000 SPORT FDA UDI
- Model / Reference
- 98-1760 FDA UDI
- Description
- BATTERY PACK LITH/ION FS 6000 SPORT FDA UDI
Identifiers
- Catalog Number
- 98-1760 FDA UDI
- Primary DI / UDI-DI
- M6339817600 FDA UDI
- FDA Product Code
- HPP FDA UDI
- GMDN Term
- Loupe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4335 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Loupe
Jedmed by JEDMED Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Loupe.
- LED LOUPE LIGHT — SONTEC INSTRUMENTS, INC. · Class I
- OMEGA 500 LED MODULE — SONTEC INSTRUMENTS, INC. · Class I
- LOUPE CARRIER — SONTEC INSTRUMENTS, INC. · Class I
- I-VIEW — SONTEC INSTRUMENTS, INC. · Class I
- MINI 3000 COMBINATION SET — SONTEC INSTRUMENTS, INC. · Class I
- HIGH RESOLUTION LED LOUPE — SONTEC INSTRUMENTS, INC. · Class I
- LIGHT WEIGHT HEAD BAND — SONTEC INSTRUMENTS, INC. · Class I
- iZoom Loupes — DENTLIGHT INC. · 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
- JEDMED Instrument Company
Sources (1)
- FDA UDI d6b50b9a-0d0a-485f-9e34-1aee3f568ac1 34 fields · synced May 30, 2026