DEVICE: NA (04546540695222)

Device Identifier (DI) Information

NA
62-00542
In Commercial Distribution
62-00542
Stryker Leibinger GmbH & Co. KG
04546540695222
GS1

1
316153956 *Terms of Use
UNIVERSAL 2.0MP VARIABLE CHEEK RETRACTOR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Basic dental retractor A hand-held dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access and to afford them protection during oral surgical procedures. It is made of high-grade stainless steel. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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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
Length: 88.0 Millimeter
Width: 20.0 Millimeter
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Device Record Status

dbc922dd-f497-47fc-a509-df8d8a049cf4
March 29, 2018
2
October 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
No Customer Contact currently defined
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