AccessGUDID - DEVICE: NA (EOBN270518S0)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Laser Surgery Fiber - DiLA’S® Hemorrhoid Probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OBERON GmbH Fiber Technologies

Primary DI Number: EOBN270518S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312889060 *Terms of Use

Device Description: Proctology - Hemorrhoid Fiber Probe, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red, black bend protection, LUER adapter, distal flat tip with silica conical capillary dome, capillary OD 1800µm, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, double packed

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 [?]
K140470	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: 68c8c3db-3479-4377-b763-0058270af06d
Public Version Date: June 19, 2024
Public Version Number: 1
DI Record Publish Date: June 11, 2024