DEVICE: HEADLUX LED SET (B366HDL2201)
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If so, send a picture of the label to
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Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
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| 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.
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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 |
|---|
| Handling Environment Temperature: between 10 and 40 Degrees Celsius |
| Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Storage Environment Temperature: between -40 and 55 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d7f7d8ee-2c8f-4c8f-9115-ad138fd25c8a
June 21, 2022
1
June 10, 2022
June 21, 2022
1
June 10, 2022
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
[?]
786-483-7490
ytzielo@ecleris.com
ytzielo@ecleris.com