FDA.reportPublic FDA data

IBC Aortic Punch, Long, 4.0mm

Primary DI
10814321020237
Brand
IBC Aortic Punch, Long, 4.0mm
Company
Movair, Inc.
Model
APL40
Device description
The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Published
2016-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10814321020237PrimaryGS10
00814321020230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081432102023710814321020237
00814321020230008143210202308143210202300814321020230

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788403103
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013561406MPVMV50012025-03-12
00860013561413MPVMV50002025-03-12
10814321020152"FloProbe 1/4’’ x 1/4"" (Non Sterile)"3090N2016-07-12
10814321020176FloProbe 3/8’’ x 3/8” (Non Sterile)3080N 2016-07-12
10814321020213IBC Aortic Punch, Long, 2.8mmAPL282016-08-02
10814321020220IBC Aortic Punch, Long, 3.6mmAPL36 2016-08-02
10814321020244IBC Aortic Punch, Long, 4.4mmAPL442016-08-02
10814321020251IBC Aortic Punch, Long, 4.8mmAPL482016-08-02
10814321020268IBC Aortic Punch, Long, 5.2mmAPL522016-08-02
10814321020275IBC Aortic Punch, Long, 5.6mmAPL562016-08-02
10814321020282IBC Aortic Punch, Long, 6.0mmAPL602016-08-02
10814321020299IBC Aortic Punch, Medium, 2.8mmAPM282016-08-02
10814321020305IBC Aortic Punch, Medium, 3.6mmAPM362016-08-02
10814321020312IBC Aortic Punch, Medium, 4.0mmAPM402016-08-02
10814321020329IBC Aortic Punch, Medium, 4.4mmAPM442016-08-02
10814321020336IBC Aortic Punch, Medium, 4.8mmAPM482016-08-02
10814321020343IBC Aortic Punch, Medium, 5.2mmAPM522016-08-02
10814321020350IBC Aortic Punch, Medium, 5.6mmAPM562016-08-02
10814321020367IBC Aortic Punch, Medium, 6.0mmAPM602016-08-02
00814321020438FloPump6500S6500S2021-03-12

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Primary DI, Brand, Company table
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00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
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00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
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14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
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03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
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00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24