AccessGUDID - DEVICE: Pixa (00853460007030)

GUDID

Device Identifier (DI) Information

Brand Name: Pixa
Version or Model: 85-10-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85-10-1000
Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.

Primary DI Number: 00853460007030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065016344 *Terms of Use

Device Description: Tablet, Pixa

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?
61583	Endoscopic device remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7e9916a-4a4c-4d8d-a576-4e42448b28d0
Public Version Date: February 22, 2019
Public Version Number: 5
DI Record Publish Date: December 04, 2017