AccessGUDID - DEVICE: Fiber Optic Light Cable (00857580006317)

GUDID

Device Identifier (DI) Information

Brand Name: Fiber Optic Light Cable
Version or Model: 3.0mm bundle diameter, 9' length, bifurcated cable
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GULF FIBEROPTICS, INC.

Primary DI Number: 00857580006317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017416582 *Terms of Use

Device Description: A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. 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 fiber optic bundle. This is a reusable device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35507	Fibreoptic light cable	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFS	Image, Illumination, Fiberoptic, For Endoscope
HBI	Illuminator, Fiberoptic, Surgical Field

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021931	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a50e093-3f80-48b4-9ba2-dacf5cde70ae
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016