AccessGUDID - DEVICE: NA (00681490069298)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 3118515
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00681490069298
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: STYLETS 3118515 10PK IRRIGATION

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:	No
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?
64128	Surgical instrument/endoscope cleaning adaptor	A device intended to connect the lumen of an appropriate surgical instrument, endoscope, and/or other cleaning tool, to the tubing of a device washer/decontaminator, or a tap, to facilitate an improved intraluminal flush and/or other cleaning of the instrument. It is typically used for pre-cleaning (i.e., removal of gross blood and other organic debris) prior to disinfection or sterilization. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K791407	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: d6ea6070-970e-4f25-b1bb-a61c389269b5
Public Version Date: October 23, 2019
Public Version Number: 5
DI Record Publish Date: May 02, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20681490069292	10	00681490069298	2018-10-24	Not in Commercial Distribution	PK

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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