AccessGUDID - DEVICE: Cochlear™ Nucleus® Implant Bandage and Splint Kit for MRI (09321502038775)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Nucleus® Implant Bandage and Splint Kit for MRI
Version or Model: P773147
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P773147
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502038775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: N/A

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
59049	General-purpose medical fibre padding	A roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	137

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
Special Storage Condition, Specify: FALSE

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b19dbe2-3bd5-467d-9f36-d351a0af5d51
Public Version Date: September 10, 2021
Public Version Number: 5
DI Record Publish Date: September 14, 2016