AccessGUDID - DEVICE: Otomag™ Attract™ Magnetic Spacer (00643169644748)

GUDID

Device Identifier (DI) Information

Brand Name: Otomag™ Attract™ Magnetic Spacer
Version or Model: S0266-09
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00643169644748
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: BASE PLATE S0266-09 9 DOT BLACK

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":	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?
61745	Head-worn bone-conduction hearing aid holder, reusable	A device intended to be fixed/worn on a patient’s head to hold a head-worn bone-conduction hearing aid. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat) or worn like a headband. It may include dedicated devices (e.g., scale) used in the fitting process. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXB	Hearing aid, bone conduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102199	000

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: ac8bc067-1c09-4d5b-b08f-9464ab47c8e1
Public Version Date: May 22, 2024
Public Version Number: 6
DI Record Publish Date: April 15, 2016