AccessGUDID - DEVICE: Mimix (20845854902483)

GUDID

Device Identifier (DI) Information

Brand Name: Mimix
Version or Model: LE-40SHP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LE-40SHP
Company Name: Conmed Corporation

Primary DI Number: 20845854902483
Issuing Agency: GS1
Commercial Distribution End Date: August 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Mimix 35 Degree Spherical Bur, 4.0mm

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?
45553	Orthopaedic bur, single-use	A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Angle: 35 degree

Device Record Status

Public Device Record Key: bf8470ac-ec9f-4778-964f-2fde5a691c56
Public Version Date: August 23, 2021
Public Version Number: 2
DI Record Publish Date: April 28, 2020

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

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