AccessGUDID - DEVICE: NA (00681490195317)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 9124105
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00681490195317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: SEPTAL BUTTON 9124105 NASAL 6CM DIA.

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:	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?
46397	Nasal septal button	A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LFB	BUTTON, NASAL SEPTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K781529	000

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
Outer Diameter: 6.0 Centimeter

Device Record Status

Public Device Record Key: 0c45bd29-bd46-4163-8838-0a5c90dce18c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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