DEVICE: Stratis® (00856457003312)

Device Identifier (DI) Information

Stratis®
C501-34
In Commercial Distribution
C501-34
PHARMAJET, INC.
00856457003312
GS1

10
609816892 *Terms of Use
Stratis® 0.5mL Syringe, 10-up
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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
Metered-delivery hypodermic syringe A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KZE Injector, Fluid, Non-Electrically Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111517 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

a7dfdb6e-f531-4a71-b33b-fcf2a3ee0c40
July 06, 2018
3
September 19, 2016
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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
00856457003350 10 00856457003312 In Commercial Distribution Inner Pack
10856457003357 10 00856457003350 In Commercial Distribution Case
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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: 00856457003404 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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