DEVICE: Instrapac (05010058080188)
Device Identifier (DI) Information
Instrapac
8018
In Commercial Distribution
8018
ROBINSON HEALTHCARE LIMITED
8018
In Commercial Distribution
8018
ROBINSON HEALTHCARE LIMITED
Instrapac Wards Carver No. 2 X 40
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
64036 | Dental restoration carver, amalgam, single-use |
A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EKH | Carver, Dental Amalgam, Operative |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry and keep out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5288746a-1982-4f65-bcd0-dbb395224ef2
July 01, 2025
1
June 23, 2025
July 01, 2025
1
June 23, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05010058180185 | 40 | 05010058080188 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441909735502
ASKVCI@vernacare.com
ASKVCI@vernacare.com