DEVICE: Gel Cord Clear Topical Hemostatic Gel ProPack (00310866000831)
Device Identifier (DI) Information
Gel Cord Clear Topical Hemostatic Gel ProPack
15840
In Commercial Distribution
15840
PASCAL COMPANY, INC.
15840
In Commercial Distribution
15840
PASCAL COMPANY, INC.
25% aluminum sulfate gel, 12 - 0.75g syringe; no color
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 0.75 Gram |
Device Record Status
28c835dd-9563-41ab-8963-9c0c1c6b5db6
March 01, 2019
1
January 29, 2019
March 01, 2019
1
January 29, 2019
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:
00310866001715
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004268051
pascal@pascaldental.com
pascal@pascaldental.com