AccessGUDID - DEVICE: Doctor Smile / Doctor Diode Laser (08056093611106)

GUDID

Device Identifier (DI) Information

Brand Name: Doctor Smile / Doctor Diode Laser
Version or Model: Protective eye wear
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LOEYW004.0
Company Name: LAMBDA SPA

Primary DI Number: 08056093611106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428482616 *Terms of Use

Device Description: Eye protection (LOEWY 004.0) against laser light at 810 nm

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:	No
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?
36309	Laser beam eye protector, patient	A protective device that is designed to be placed either under or over the patient's eyelids in order to protect the eyes from injury during laser surgery.	Obsolete	false
17650	Laser beam eye protector, staff	A protective device that is designed to be used by the surgical staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery. It will typically be designed as goggles or special spectacles containing a filter glass that provides adequate visual transmission with high optical density (attenuation) for the specified laser wavelength which they will be using.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091562	000
K102036	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 028d46a0-647b-446f-9d9f-fb21d32fdb21
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016