DEVICE: SEDASYS (10705036003434)

Device Identifier (DI) Information

SEDASYS
SEDCAS01
Not in Commercial Distribution
SEDCAS01
ETHICON ENDO-SURGERY, INC.
10705036003434
GS1
August 09, 2017
1
123407392 *Terms of Use
SEDASYS DRUG DELIVERY CASSETTE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Rifabutin IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of rifabutin in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
PDR Computer-assisted personalized sedation system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
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

534ed14f-7591-4dab-ae2e-9b69e62d73b8
March 29, 2018
2
September 17, 2014
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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
20705036003431 20 10705036003434 2017-08-09 Not in Commercial Distribution BOX
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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