AccessGUDID - DEVICE: Ponto (05712149009640)

GUDID

Device Identifier (DI) Information

Brand Name: Ponto
Version or Model: M52321
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M52321
Company Name: Oticon Medical AB

Primary DI Number: 05712149009640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554563994 *Terms of Use

Device Description: Abutment extension, 1 mm

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

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

GMDN Preferred Term Name	GMDN Definition
Orthopaedic implant/instrument adaptor, reusable	A connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant/instrument adaptor, reusable

A connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
LXB	Hearing Aid, Bone Conduction
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Height: 1 Millimeter

Device Record Status

Public Device Record Key: 5ec51ba9-7d35-46e4-9d3b-a50e7b533bfc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016