FDA.reportPublic FDA data

Open Pivot™

Primary DI
00613994959546
Brand
Open Pivot™
Company
MEDTRONIC, INC.
Model
558
Device description
ACCY 558 ACTUATOR PACKAGE AVG
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994959546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994959546006139949595466139949595460613994959546

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis sizer handleA hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039931SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039948SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040043SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040050SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040067SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040074SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040081SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040098SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040104SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040111SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040128SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039788SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039795SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039863SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039870SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27