AccessGUDID - DEVICE: Midas Rex® (10721902833547)

GUDID

Device Identifier (DI) Information

Brand Name: Midas Rex®
Version or Model: MH109
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS

Primary DI Number: 10721902833547
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098308849 *Terms of Use

Device Description: ACCY MH109 LEGEND GOLD MOTOR HANDLE

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?
41267	Surgical power tool system control unit, pneumatic	A pneumatically-powered (gas-powered) component of a surgical power tool system intended to regulate the gas pressure supplied to the pneumatic handpiece/motor (not included) and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBB	MOTOR, DRILL, PNEUMATIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020069	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a3f8bd0f-939d-4abd-a1e2-3eca3408bf18
Public Version Date: November 15, 2023
Public Version Number: 5
DI Record Publish Date: June 26, 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
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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