FDA.reportPublic FDA data

SCANLAN® A/V Punch

Primary DI
00846159025781
Brand
SCANLAN® A/V Punch
Company
SCANLAN INTERNATIONAL INC
Model
1001-602B
Catalog number
1001-602B
Device description
"Single-Use A/V Punch,Bulk Non-Sterile, 4.0 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159025781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159025781008461590257818461590257810846159025781

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039269SCANLAN® ForcepsQ26049-4Q26049-42026-05-26
00846159039276SCANLAN® ForcepsQ26065-4NQ26065-4N2026-05-26
00846159039283SCANLAN® ForcepsQ27036-34Q27036-342026-05-26
00846159039290SCANLAN® ForcepsQ27047-34NQ27047-34N2026-05-26
00846159039306SCANLAN® ClampQ27052-2Q27052-22026-05-26
00846159039313SCANLAN® ClampQ27058-9Q27058-92026-05-26
00846159039320SCANLAN® ForcepsQ27064-4Q27064-42026-05-26
00846159039337SCANLAN® ForcepsQ27080-34NQ27080-34N2026-05-26
00846159039344SCANLAN® ForcepsQ27081-4NQ27081-4N2026-05-26
00846159039351SCANLAN® ClampQ27107-2Q27107-22026-05-26
00846159039368SCANLAN® ClampQ27108-2Q27108-22026-05-26
00846159039375SCANLAN® ClampQ27109-2Q27109-22026-05-26
00846159039382SCANLAN® ClampQ27110-2Q27110-22026-05-26
00846159039399SCANLAN® ForcepsQ27112-34Q27112-342026-05-26
00846159039405SCANLAN® ForcepsQ28011-4Q28011-42026-05-26
00846159039412SCANLAN® ClampQ28016-9Q28016-92026-05-26
00846159039429SCANLAN® ClampQ28018Q280182026-05-26
00846159039436SCANLAN® ClampQ28027-32Q28027-322026-05-26
00846159039443SCANLAN® ForcepsQ28033-4Q28033-42026-05-26
00846159039450SCANLAN® ClampQ28046-2Q28046-22026-05-26

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Primary DI, Brand, Company table
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10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
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