DEVICE: MAP SYSTEM MAP SYRINGE (07640159160045)

Device Identifier (DI) Information

MAP SYSTEM MAP SYRINGE
20285
In Commercial Distribution

Produits dentaires S.A.
07640159160045
GS1

1
480420090 *Terms of Use
1 Sterilisable aluminium case 185x95x30 mm 1 Stainless steel syringe 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 8 Spare POM plungers N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi cleaning curette N°1 Red + N°0 Yellow + N°2 Blue 1 paste cleaning device stops N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 1 Stainless steel well diam 14mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
35696 Dental amalgam carrier
A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKI Carrier, Amalgam, Operative
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

fbe1083c-ff39-4d65-87d3-6a3cc23fe403
September 02, 2022
1
August 25, 2022
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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
No Package DIs found
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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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+41219212631
info@pd-dental.com
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