AccessGUDID - DEVICE: Skater™ Nephrostomy Catheter (00886333001088)

GUDID

Device Identifier (DI) Information

Brand Name: Skater™ Nephrostomy Catheter
Version or Model: 755607025E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 755607025
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333001088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Skater™ Nephrostomy Catheter Locking Pigtail 7Fr x 25cm

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?
10735	Nephrostomy catheter	A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBO	Catheter, Nephrostomy, General & Plastic Surgery

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
Special Storage Condition, Specify: Keep dry and away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7Fr x 25cm

Device Record Status

Public Device Record Key: 5f40a628-af3e-4a02-b3e2-7cf2c5a0a363
Public Version Date: July 21, 2022
Public Version Number: 1
DI Record Publish Date: July 13, 2022