AccessGUDID - DEVICE: SOL® (D813LR10080)

GUDID

Device Identifier (DI) Information

Brand Name: SOL®
Version or Model: LR1008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LR1008
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: D813LR10080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: LASER EYEWEAR

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):	No
Over the Counter (OTC):	Yes
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?
38884	Radiation shielding goggles/spectacles	A personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.	Active	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: c2dfa3c5-8dd5-4389-9098-6ed1594340cd
Public Version Date: September 30, 2022
Public Version Number: 1
DI Record Publish Date: September 22, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18004336628
Email: info@denmat.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES