AccessGUDID - DEVICE: NA (07613327064131)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0504803115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0504-803-115
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327064131
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: 3.0 Fr., Flat Wire Basket, Do not use if package is damaged

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?
35808	Stone/foreign-body extraction set	A collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGO	DISLODGER, STONE, FLEXIBLE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 115.0 Centimeter

Device Record Status

Public Device Record Key: 42338e05-299d-4c24-84d8-9e7b8c760acf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016