DEVICE: Darby Dental Supply, LLC (00889813037942)

Device Identifier (DI) Information

Darby Dental Supply, LLC
9509454
In Commercial Distribution
9509454
DARBY DENTAL SUPPLY, LLC
00889813037942
GS1

1
825137818 *Terms of Use
SPARE POINT B CROWN REMOVER
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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?
35552 Tooth extraction forceps
A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EIS REMOVER, CROWN
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

3cfc6a8d-d6e0-4505-932e-003453b6c4eb
June 03, 2020
1
May 26, 2020
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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(516)688-6800 6431
Robyn.livingston@darby.com
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