FDA.reportPublic FDA data

CleanCut 4.5 mm Nonsterile Bullet Aortic Punch

Primary DI
20634624324521
Brand
CleanCut 4.5 mm Nonsterile Bullet Aortic Punch
Company
QUEST MEDICAL INC
Model
RCB45BNS
Catalog number
RCB45BNS
Device description
.
Published
2019-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20634624324521PrimaryGS10
00634624324527Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462432452120634624324521
00634624324527006346243245276346243245270634624324527

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
Ethylene Oxide

Regulatory Flags#

DUNS number
041810693
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
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00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05
00634624901032Q2 IV Administration SetASV103Y2020-06-25
00634624911048High-Flow Extension SetHF01352022-12-12
00634624911062Precision Delivery IV Extension SetPD06F2022-10-26
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624921115High-Flow 4-Way Stopcock ExtensionHFSTV022022-12-05
00634624921245High-Flow 4-Way Stopcock ExtensionHFST012022-11-30
00634624921382Precision Delivery IV Extension SetPDB05CV12022-09-15
00634624921399Precision Delivery IV Extension SetPDB05CV22022-09-15
00634624921405Precision Delivery IV Extension SetPDBM05CV12022-09-15

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