AccessGUDID - DEVICE: SKATER™ All-Purpose and Nephrostomy Drainage Set (00886333225194)

GUDID

Device Identifier (DI) Information

Brand Name: SKATER™ All-Purpose and Nephrostomy Drainage Set
Version or Model: 756612015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 756612015
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333225194
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: SKATER™ All-Purpose and Nephrostomy Drainage Set Locking 12F x 15cm

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?
47796	Multi-purpose percutaneous abdominothoracic drainage catheter	A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.	Active	true

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: 12F x 15cm

Device Record Status

Public Device Record Key: a3264f33-e915-4d6a-b27f-c0d17811d770
Public Version Date: July 21, 2022
Public Version Number: 1
DI Record Publish Date: July 13, 2022