DEVICE: EXEL CURVED TIP 10ml SYRINGE (00020221262674)

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Device Record History
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Device Identifier (DI) Information
EXEL CURVED TIP 10ml SYRINGE
26267
In Commercial Distribution
26267
Exel International
00020221262674
GS1

1
180572216 *Terms of Use
EXEL CURVED TIP 10ml SYRINGE; BULK, NON-STERILE, 50PC/BX, 500PC/CS, 2CS/CRTN
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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?
35390 Irrigation syringe
A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, Piston
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K861153 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
9641a2ba-ecf6-432d-a941-42591eccc829
March 23, 2023
1
March 15, 2023
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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
10020221262671 50 00020221262674 In Commercial Distribution Inner box
20020221262678 10 10020221262671 In Commercial Distribution Outer box
30020221262675 2 20020221262678 In Commercial Distribution Shipping carton
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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

[?]
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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