AccessGUDID - DEVICE: ALN Pre-Curved RS (03760017680110)

GUDID

Device Identifier (DI) Information

Brand Name: ALN Pre-Curved RS
Version or Model: FT.902010/VS2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.L.N.

Primary DI Number: 03760017680110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 272983094 *Terms of Use

Device Description: The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

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):	No
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?
45162	Vena cava filter extraction/repositioning kit	A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTK	Filter, Intravascular, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163699	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b50b6010-7d79-475c-ac46-633f1bc073cf
Public Version Date: November 26, 2018
Public Version Number: 1
DI Record Publish Date: October 26, 2018