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Ats Simulus®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
ATS SIMULUS® FDA UDI
Generic Name
Mitral/tricuspid annuloplasty ring FDA UDI
Device Name
BAND SIM FB 700FC39 FLEXIBLE 39MM FDA UDI
Model / Reference
700FC39 FDA UDI
Description
BAND SIM FB 700FC39 FLEXIBLE 39MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169301221 FDA UDI
510(k) Number
K052899 FDA UDI
FDA Product Code
KRH FDA UDI
GMDN Term
Mitral/tricuspid annuloplasty ring FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 39.0 Millimeter FDA UDI

Ats Simulus® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K052899 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI f02fb730-0938-47b2-af3b-0ed15a4ff28c 38 fields · synced May 31, 2026