AccessGUDID - DEVICE: Gel Cord Clear Topical Hemostatic Gel 30g Jar (00310866000848)

GUDID

Device Identifier (DI) Information

Brand Name: Gel Cord Clear Topical Hemostatic Gel 30g Jar
Version or Model: 15810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15810
Company Name: PASCAL COMPANY, INC.

Primary DI Number: 00310866000848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009260217 *Terms of Use

Device Description: 25% aluminum sulfate gel 30g jar; No color

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?
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	Cord, Retraction

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
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ce7cc33-fc10-4cc4-b289-91d5ef9f031f
Public Version Date: March 04, 2019
Public Version Number: 1
DI Record Publish Date: January 30, 2019