AccessGUDID - DEVICE: Freestyle™ (00763000318338)

GUDID

Device Identifier (DI) Information

Brand Name: Freestyle™
Version or Model: 7990SET
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000318338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: OBTURATORS 7990SET FREESTYLE 26L CE

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):	No
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?
47684	Heart valve annulus sizer, reusable	A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTI	SIZER, HEART-VALVE, PROSTHESIS

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: 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
Device Size Text, specify: The Freestyle aortic obturators include the following sizes: 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, and 29 mm.

Device Record Status

Public Device Record Key: 096722d5-fddf-41a5-99df-6cc1d5ea3828
Public Version Date: December 17, 2024
Public Version Number: 3
DI Record Publish Date: April 01, 2021

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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