AccessGUDID - DEVICE: ScopeSafe Laser Fiber with SoftTip (B145116130)

GUDID

Device Identifier (DI) Information

Brand Name: ScopeSafe Laser Fiber with SoftTip
Version or Model: 11613
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SU-200-ST
Company Name: OPTICAL INTEGRITY INC

Primary DI Number: B145116130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024050887 *Terms of Use

Device Description: 272 micrometer ScopeSafe™ Laser Fiber with SoftTip™

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?
61474	General/multiple surgical laser system beam guide, reusable	A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable 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: 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
Outer Diameter: 272 Micrometer

Device Record Status

Public Device Record Key: 961c4bd0-51c6-4a0c-a4a4-d91fd96d37cf
Public Version Date: June 02, 2023
Public Version Number: 8
DI Record Publish Date: November 03, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B145116135	5	B145116130	In Commercial Distribution	carton
B145116131	5	B145116130	In Commercial Distribution	carton
B145116831	5	B145116130	In Commercial Distribution	carton
B145116150	1	B145116130	In Commercial Distribution	carton
B145116171	5	B145116150	In Commercial Distribution	carton