AccessGUDID - DEVICE: Multi-Snare® (04046964349379)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-Snare®
Version or Model: 612974
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 612974
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964349379
Issuing Agency: GS1
Commercial Distribution End Date: May 12, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: MULTI-SNARE 15MMX125CM W/5FRX105CM

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Intravascular catheter-snare	A sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

GMDN Preferred Term Name

GMDN Definition

Intravascular catheter-snare

A sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

FDA Product Code

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Product Code	Product Code Name
DXE	CATHETER, EMBOLECTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011783	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52e2bcc0-15bc-4d3f-99b2-e9afc52237a7
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: August 09, 2016