AccessGUDID - DEVICE: SureFlex (00878953000190)

GUDID

Device Identifier (DI) Information

Brand Name: SureFlex
Version or Model: 8013045
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS

Primary DI Number: 00878953000190
Issuing Agency: GS1
Commercial Distribution End Date: January 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 796308653 *Terms of Use

Device Description: 910 µm Lithotripsy Fiber

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?
47785	Urogenital surgical laser system beam guide, single-use	A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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: 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
Device Size Text, specify: 910um Fiber Core

Device Record Status

Public Device Record Key: e46bfd2e-d5ab-4373-9911-edd2c6182626
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016