FDA.report

Cordless high performance LED headlight

Primary DI
04053755180318
Brand
Cordless high performance LED headlight
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-122-00
Catalog number
10-122-00
Device description
"HighLite" with comfortable headband transformer & charger, with mobile
Published
2022-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053755180318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053755180318040537551803184053755180318

GMDN Terms

TermDefinition
Head-worn fibreoptic lightA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags

DUNS number
332893028
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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