DEVICE: Instrapac (05010058078109)

Device Identifier (DI) Information

Instrapac
7810
In Commercial Distribution
7810
ROBINSON HEALTHCARE LIMITED
05010058078109
GS1

1
237799775 *Terms of Use
Instrapac Amalgam Condenser X 40
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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?
64051 Dental amalgam condenser, single-use
A sterile, hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKG Condenser, Amalgam And Foil, Operative
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry and keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8a07d6c0-33f4-4f66-b82b-1a7d8eeaf3ab
July 01, 2025
1
June 23, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05010058178106 40 05010058078109 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441909735502
ASKVCI@vernacare.com
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