AccessGUDID - DEVICE: Roth Net Platinum (00816765011973)

GUDID

Device Identifier (DI) Information

Brand Name: Roth Net Platinum
Version or Model: 00715050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00715050
Company Name: US Endoscopy

Primary DI Number: 00816765011973
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.

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?
46454	Gastrointestinal/airway foreign body retrieval basket, single-use	A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDI	SNARE, FLEXIBLE
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 230 Centimeter
Width: 4 Centimeter
Outer Diameter: 2.5 Millimeter

Device Record Status

Public Device Record Key: 0d84c2ba-29f5-4ffd-90fa-c8bed04dfee6
Public Version Date: September 11, 2023
Public Version Number: 7
DI Record Publish Date: September 17, 2016