DEVICE: Uni-Tip -Package of 25 (D248B16351)

Device Identifier (DI) Information

Uni-Tip -Package of 25
B1635
In Commercial Distribution

HAGER WORLDWIDE, INC.
D248B16351
HIBCC

25
009277971 *Terms of Use
Chrome-plated air/water syringe
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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?
65430 Dental delivery system irrigation handpiece tip
A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ECB UNIT, SYRINGE, AIR AND/OR WATER
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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

[?]
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

20566372-34e6-4bc4-944f-c3cf05e96fa4
September 20, 2023
1
September 12, 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
No Package DIs found
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Secondary DI

[?]
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
Yes
D248B16280
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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