AccessGUDID - DEVICE: CASE & LENS (00192896071216)

GUDID

Device Identifier (DI) Information

Brand Name: CASE & LENS
Version or Model: C-000.17.205
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-000.17.205
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896071216
Issuing Agency: GS1
Commercial Distribution End Date: December 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: CASE & LENS

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?
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJL	Lens, condensing, diagnostic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

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: 0b40e1cd-946f-462c-bcce-9f33165006ae
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: September 17, 2018