FDA.reportPublic FDA data

CleanCut Rotating Aortic Punch, 4.0 mm

Primary DI
10634624334004
Brand
CleanCut Rotating Aortic Punch, 4.0 mm
Company
QUEST MEDICAL INC
Model
RCC40
Catalog number
RCC40
Published
2019-10-10
Public version status
New
Distribution status
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
20634624334001PackageGS16In Commercial Distribution
10634624334004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462433400120634624334001
1063462433400410634624334004

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.

Regulatory Flags#

DUNS number
041810693
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

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