DEVICE: DURA SYRINGE 3-WAY SYRINGE-adec STYLE WITH QUICK DISCONNECT (D248B105520)

Device Identifier (DI) Information

DURA SYRINGE 3-WAY SYRINGE-adec STYLE WITH QUICK DISCONNECT
B10552
In Commercial Distribution

HAGER WORLDWIDE, INC.
D248B105520
HIBCC

1
009277971 *Terms of Use
Dura Syringe Handpiece with Quick Disconnect
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
45131 Dental delivery system irrigation handpiece
A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EHZ Evacuator, oral cavity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
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

e2226644-a016-4aa4-a297-fe1650d0bd0e
August 24, 2023
1
August 16, 2023
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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

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No
No
No
No
No CLOSE

Customer Contact

[?]
+1(828)624-3319
d.pritchard@hagerworldwide.com
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