AccessGUDID - DEVICE: Medichoice (10885632146688)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: CL8222
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632146688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Combo No FDA Class II Kit No MFG Date MRI Unsafe Medical Device-Tax Non Sterile Not Nat Rubber Ltx Prescription Use RX Reusable

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
58068	Electrosurgical/ultrasonic surgical system tester interface	A non-sterile electrical connecting device designed to provide an interface between a commonly used electrical output analyser/equipment and an electrosurgical system generator and an ultrasonic surgical system generator, or a combination electrosurgical/ultrasonic surgical system generator when being tested for power output in a non-clinical setting. Commonly known as a verification key, it is typically used by a hospital clinical engineer when testing the generators during routine maintenance or inspection and provides standard connector components (e.g., banana plug receptacles) to allow simpler interface with a custom generator connector. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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
Handling Environment Temperature: between 0 and 40 Degrees Fahrenheit
Special Storage Condition, Specify:
Special Storage Condition, Specify: Avoid Freezing and Excessive Heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9199ef53-d79a-4753-b73a-7881c49419a4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016