DEVICE: FOBI Medical (B701FOBLED55000)
Device Identifier (DI) Information
FOBI Medical
FOBLED5500
In Commercial Distribution
FOB LED5500
FIBEROPTIC BULBS, INC.
FOBLED5500
In Commercial Distribution
FOB LED5500
FIBEROPTIC BULBS, INC.
LED headlight with two rechargable batteries, battery charger & carrying case.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46807 | Head-worn lamp |
An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HPP | Headlamp, Operating, Battery-Operated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3f92649d-2050-4298-b0ef-04dace45f541
March 21, 2019
3
October 31, 2018
March 21, 2019
3
October 31, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
281-255-2887
wkp@fobi.us
wkp@fobi.us