AccessGUDID - DEVICE: Pulec (00681490036115)

GUDID

Device Identifier (DI) Information

Brand Name: Pulec
Version or Model: 117200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00681490036115
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: SHUNT 117200 PULEC ENDOLYMPHATIC C-FLEX

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?
16033	Endolymphatic shunt	A sterile tube or sheet surgically implanted in the membranous labyrinth of the inner ear to drain excess endolymphatic fluid typically as treatment for Meniere's disease, an inner ear disorder. The device permits unrestricted flow of the fluid from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. It is typically made of silicone. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ESZ	TUBE, SHUNT, ENDOLYMPHATIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K834094	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
Length: 18.5 Millimeter

Device Record Status

Public Device Record Key: a267bfb9-c089-4bfc-8644-128db1397f71
Public Version Date: June 10, 2024
Public Version Number: 4
DI Record Publish Date: June 25, 2015

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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