FDA.report

n.a.

Primary DI
04048551124444
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
310070
Catalog number
310070
Device description
Headband, fully adjustable
Published
2016-09-23
Public version status
Update
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
FSRLight, headband, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FSRLight, Headband, SurgicalOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551124444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551124444040485511244444048551124444

GMDN Terms

TermDefinition
Headband, reusableA device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags

DUNS number
315731430
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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