FDA.reportPublic FDA data

NA

Primary DI
20763000122298
Brand
NA
Company
MEDTRONIC, INC.
Model
APU560
Device description
AORTIC PUNCH LH 560 SUA
Published
2019-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20763000122298PrimaryGS10
00763000122294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300012229820763000122298
00763000122294007630001222947630001222940763000122294

GMDN Terms#

Term, Definition table
TermDefinition
Aorta punch, single-useA sterile, manual surgical instrument designed to cut a circular or elliptical plug of tissue from the wall of the aorta to create an anastomosis site during vascular surgery. It consists of a pointed, cone-shaped, disk-like tip on the end of a plunger that is inserted through a small incision made; its diameter/size corresponds to the cut hole. Behind the tip is a thinner section which entraps (holds) the tissue as the sharp circular/elliptical blade is pressed down the plunger into and through the tissue. It is typically made of steel and plastic and is available in various punch sizes. It can equally be used to punch holes in other vessels when needed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
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
08022057015747JOSEPH LAMELAS Atrial Lift SystemCORCYM SRLDWS2026-02-03
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLDWS2026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerCORCYM SRLDWS2026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
G4533324301300PEAK MEDICALPeak Medical Distribution Inc.DWS2024-09-17
G586NS30105710Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G586NSCV511010Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G45352745404BC0PEAK MEDICALPeak Medical Distribution Inc.DWS2024-02-01
07898506818204QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818211QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818198QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506818228QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853106QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853113QuinelatoSchobell Industrial LtdaDWS2023-01-09
07899798203846QuinelatoSchobell Industrial LtdaDWS2022-12-16
ESOT001241NAS & T AGDWS2022-09-15
ESOT001251NAS & T AGDWS2022-09-15
ESOT002331NAS & T AGDWS2022-09-15
ESOT002481NAS & T AGDWS2022-09-15
ESOT002491NAS & T AGDWS2022-09-15
ESOT002501NAS & T AGDWS2022-09-15
ESOT002751NAS & T AGDWS2022-09-15
ESOT002761NAS & T AGDWS2022-09-15
ESOT003241NAS & T AGDWS2022-09-15
ESOT005011NAS & T AGDWS2022-09-15
ESOT005431NAS & T AGDWS2022-09-15
ESOT005741NAS & T AGDWS2022-09-15
ESOT005771NAS & T AGDWS2022-09-15
ESOT005881NAS & T AGDWS2022-09-15