FDA.report

SCANLAN® Tunnelers

Primary DI
00846159023589
Brand
SCANLAN® Tunnelers
Company
SCANLAN INTERNATIONAL INC
Model
9009-14
Catalog number
9009-14
Device description
A/V Access Tunneler
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159023589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159023589008461590235898461590235890846159023589

GMDN Terms

TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00846159039412SCANLAN® ClampQ28016-9Q28016-92026-05-26
00846159039429SCANLAN® ClampQ28018Q280182026-05-26
00846159039436SCANLAN® ClampQ28027-32Q28027-322026-05-26
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