AccessGUDID - DEVICE: Ponto (05712149009688)

GUDID

Device Identifier (DI) Information

Brand Name: Ponto
Version or Model: M52329
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M52329
Company Name: Oticon Medical AB

Primary DI Number: 05712149009688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554563994 *Terms of Use

Device Description: MIPS Back-Up Kit, 3 mm

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
ENT surgical procedure kit, non-medicated, single-use	A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
MAH	Hearing Aid, Bone Conduction, Implanted

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: Yes
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
Length: 3 Millimeter

Device Record Status

Public Device Record Key: c48c0d73-513f-4b99-b731-a24e44a5e51f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016