AccessGUDID - DEVICE: Single use Surgical Optical Fiber (08033945937973)

GUDID

Device Identifier (DI) Information

Brand Name: Single use Surgical Optical Fiber
Version or Model: OFH302711
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EMP-FBX200BHS
Company Name: QUANTA SYSTEM SPA

Primary DI Number: 08033945937973
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 436045833 *Terms of Use

Device Description: Single use Surgical Ball tip Optical Fiber ø 272 µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.

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 [?]
K180158	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 255f5a6d-f140-4ce7-8fc7-b8938f2d430b
Public Version Date: August 25, 2022
Public Version Number: 5
DI Record Publish Date: March 07, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
08033945937997	2	08033945937980	2022-08-24	Not in Commercial Distribution	carton box
08033945937980	5	08033945937973	2022-08-24	Not in Commercial Distribution	carton box