AccessGUDID - DEVICE: Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution (D0026751101)

GUDID

Device Identifier (DI) Information

Brand Name: Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution
Version or Model: 675130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 675110
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026751101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Hemoban® Gel Complete Package

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
46423	Gingival retraction solution	A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.	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: 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
Special Storage Condition, Specify: Keep out of direct sunlight and store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze.
Storage Environment Temperature: between 18 and 29 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4220b99e-7003-4d83-bb8c-300508573625
Public Version Date: April 19, 2022
Public Version Number: 1
DI Record Publish Date: April 11, 2022