AccessGUDID - DEVICE: SCANLAN® Vascular Tunneler Sheaths and Bullet Tips (00846159000986)

GUDID

Device Identifier (DI) Information

Brand Name: SCANLAN® Vascular Tunneler Sheaths and Bullet Tips
Version or Model: 9009-18
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9009-18
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159000986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: Small (green) for grafts up to 8 mm, 20 1/2" / 52 cm (1/pkg)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35950	Vascular graft tunneller	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 750c87e2-1736-4283-9070-043f929408e0
Public Version Date: November 25, 2020
Public Version Number: 1
DI Record Publish Date: November 17, 2020