DEVICE: Fischer Ultrapak Packer (00883205015433)

Device Identifier (DI) Information

Fischer Ultrapak Packer
171
In Commercial Distribution
171
ULTRADENT PRODUCTS, INC.
00883205015433
GS1

1
013369913 *Terms of Use
Fischer's Ultrapak Packer 45° Small
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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?
31904 Dental curette, basic
A hand-held dental instrument with a spoon-shaped working end designed to scrape oral tissues. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
EJB HANDLE, INSTRUMENT, DENTAL
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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

1133c95d-6fa6-4374-99fd-615543f6a251
May 29, 2018
1
April 28, 2018
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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
No
No CLOSE

Customer Contact

[?]
+1(801)572-4200
customerservice@ultradent.com
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