DEVICE: Cordless high performance LED headlight (04053755180318)
Device Identifier (DI) Information
Cordless high performance LED headlight
10-122-00
In Commercial Distribution
10-122-00
Spiggle & Theis Medizintechnik GmbH
10-122-00
In Commercial Distribution
10-122-00
Spiggle & Theis Medizintechnik GmbH
"HighLite" with comfortable headband
transformer & charger, with mobile
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
46808 | Head-worn fibreoptic light |
A fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBA | LIGHT, SURGICAL HEADLIGHT |
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 |
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No Device Sizes |
Device Record Status
3427c34c-2388-4a2d-8418-ccb3ffccba2d
October 04, 2022
1
September 26, 2022
October 04, 2022
1
September 26, 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
[?]
+492206908165
c.winterschladen@spiggle-theis.com
c.winterschladen@spiggle-theis.com