FDA.report

Ambler Surgical

Primary DI
00190660100575
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Fiberoptic light cable
Catalog number
40-110
Device description
Fiberoptic light cable, 6' length x 5.0mm bundle diameter, gray sheathing, Karl Storz scope / Karl Storz light source (threaded) connectors
Published
2021-01-04
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
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660100575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660100575001906601005751906601005750190660100575

GMDN Terms

TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
Device count
1
DM exempt
true
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
true

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