AccessGUDID - DEVICE: SEPTODONT ADHERENCE REF SYR OPAQUE 4GM (00303620000567)

GUDID

Device Identifier (DI) Information

Brand Name: SEPTODONT ADHERENCE REF SYR OPAQUE 4GM
Version or Model: 01C2010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEPTODONT, INC

Primary DI Number: 00303620000567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012925513 *Terms of Use

Device Description: No description.

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:	Yes
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?
45870	Multi-purpose soft contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 15 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 4 Gram

Device Record Status

Public Device Record Key: 7d6e2af5-c8fa-4bad-bb62-4ef34f7ccfd3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 2016