FDA.report

SCANLAN® A/V Punch

Primary DI
00846159025811
Brand
SCANLAN® A/V Punch
Company
SCANLAN INTERNATIONAL INC
Model
1001-606B
Catalog number
1001-606B
Device description
Single-Use A/V Punch,Bulk Non-Sterile, 5.5 mm, 5-3/4"/14.5 cm long (5/pkg)
Published
2018-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159025811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159025811008461590258118461590258110846159025811

GMDN Terms

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
Radiation Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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