FDA.reportPublic FDA data

Binocular loupe, 2,5 x magnification

Primary DI
04053755118922
Brand
Binocular loupe, 2,5 x magnification
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-140-00
Catalog number
10-140-00
Device description
working distance 340 mm, in case and glasses, incl. holding band & cleaning
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJHLoupe, binocular, low power

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755118922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755118922040537551189224053755118922

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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