AccessGUDID - DEVICE: SCANLAN® John Ross Tunneler (00846159035698)

GUDID

Device Identifier (DI) Information

Brand Name: SCANLAN® John Ross Tunneler
Version or Model: 9009-32
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9009-32
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159035698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: SCANLAN® John Ross A/V Access Tunneler, Full Curve

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:	No
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?
58344	Tunnelling forceps	A hand-held manual surgical instrument designed to be used to open a soft tissue plane (tunnelling) and to pull an object, typically a tube implant or other device, back through the tunnel. It is made of metal and typically has an elongated, slender, scissors-like design with two blades that close like jaws and ring handles. It may be used during rib/rib cage internal fixation procedures. This is a reusable device intended to be sterilized prior to use.	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 9737da35-4196-4131-adbc-adbdf362be94
Public Version Date: March 03, 2022
Public Version Number: 1
DI Record Publish Date: February 23, 2022