DEVICE: Young (00302731777016)

Device Identifier (DI) Information

Young
177701
In Commercial Distribution
177701
YOUNG DENTAL MANUFACTURING I, LLC
00302731777016
GS1

1
006309355 *Terms of Use
Young Rubber Damn Frame Kit, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in.) (12.8 cm x 10.4 cm), neckbands, template and manual
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
31849 Rubber dam frame
A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJE FRAME, RUBBER DAM
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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

c1909848-e5a3-4fd4-97fd-f0e78e4adf81
October 24, 2022
1
October 16, 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
10302731777013 1 00302731777016 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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800) 325-1881
customerservice@younginnovations.com
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