AccessGUDID - DEVICE: ATS SIMULUS® (00643169300927)

GUDID

Device Identifier (DI) Information

Brand Name: ATS SIMULUS®
Version or Model: 800SC32
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169300927
Issuing Agency: GS1
Commercial Distribution End Date: July 17, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: BAND SIM SRB 800SC32 SEMI-RIGID 32MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
45577	Mitral annuloplasty ring	A circular band intended to be implanted in the heart to support a mitral valve annulus for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KRH	RING, ANNULOPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083683	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
Special Storage Condition, Specify: Store the product carton in a temperate, dry place to protect the product and minimize contamination potential.
Special Storage Condition, Specify: Store in cool dry place.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 32.0 Millimeter

Device Record Status

Public Device Record Key: c6d13455-1f59-4afd-b599-ac48659242ed
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: June 18, 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: No
Serial Number: Yes
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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