DEVICE: NA (04546540217042)

Device Identifier (DI) Information

NA
41-36790
In Commercial Distribution
41-36790
Stryker Leibinger GmbH & Co. KG
04546540217042
GS1

1
316153956 *Terms of Use
MOUTH GAG, PEDIAT., MALEK, FRAME ONLY
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Mouth gag, adjustable A mechanical device with adjustable parts that is placed between the teeth of a patient in order to maintain an open oral cavity, typically during the emergent placement of an artificial airway or for an oral/dental surgical intervention. It is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This device is also known as a jaw spreader. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LRC INSTRUMENT, ENT MANUAL SURGICAL
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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 13.0 Centimeter
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Device Record Status

33d1aacc-776f-458c-9473-85447fc914f0
March 29, 2018
2
December 08, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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