AccessGUDID - DEVICE: Invuity® Fiber Optic Cable (00816728020219)

GUDID

Device Identifier (DI) Information

Brand Name: Invuity® Fiber Optic Cable
Version or Model: Bifurcated
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110001
Company Name: INVUITY, INC.

Primary DI Number: 00816728020219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175697908 *Terms of Use

Device Description: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source.

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):	Yes
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
FST	Light, Surgical, Fiberoptic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090070	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
Length: 8 Feet

Device Record Status

Public Device Record Key: 679625ca-a8c1-49f7-a798-cb478711c4e1
Public Version Date: April 24, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2016