FDA.reportPublic FDA data

NA

Primary DI
00643169624993
Brand
NA
Company
MEDTRONIC, INC.
Model
558
Device description
ACCY 558 ACTUATOR PACKAGE AVG
Published
2025-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00643169624993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169624993006431696249936431696249930643169624993

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

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704941593PILLINGTELEFLEX INCORPORATEDDWS2026-03-23
03661219509158DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511618DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511649DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511694DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511809DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511830DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515425DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515968DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528685DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528692DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528708DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528715DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219322184DELACROIX-CHEVALIERLANDANGERDWS2026-03-16
03661219323747DELACROIX-CHEVALIERLANDANGERDWS2026-03-13
04058749009538NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009811NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009873NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009903NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043082NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043099NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043143NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043150NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043167NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749047752NAFehling Instruments GmbH & Co. KGDWS2026-03-05
00198506088957ELMED INCORPORATEDELMED INCORPORATEDDWS2026-03-03
03661219010296LANDANGERLANDANGERDWS2026-03-02
03661219138471DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138518DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138556DELACROIX-CHEVALIERLANDANGERDWS2026-03-02