AccessGUDID - DEVICE: Integra® (10381780356585)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: 003285CCNTSC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 003285CCNTSC
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780356585
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Fixed Focus Headlight Camera System (NTSC) Camera Control Unit ONLY

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":	No
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?
37332	Operating room light system	An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWC	CAMERA, TELEVISION, SURGICAL, WITH AUDIO

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6b9806d-b597-4833-8658-546339982312
Public Version Date: January 08, 2021
Public Version Number: 4
DI Record Publish Date: January 13, 2020