DEVICE: NA (10886982128935)

Device Identifier (DI) Information

NA
05.001.071
In Commercial Distribution
05001071
Synthes GmbH
10886982128935
GS1

1
486711679 *Terms of Use
IRRIGATION NOZZLE FOR EPD RECIPROCATING SAW ATTACHMENT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
47886 Surgical power tool irrigation-control device
A device designed to be activated by the surgeon to regulate the flow of irrigation fluid (normally sterile saline) to the surgical site where a rotational high-speed cutting tool [e.g., 40.000 - 90.000 revolutions per minute (rpm)] is being applied to bone; primarily to provide the fluid as a coolant to the cutting tool (e.g., a bur or drill bit) and the site to avoid necrosis. It typically consists of tubing, connectors, and a simple electrically or pneumatically activated valve in which the coolant tubing is placed and which is pinched to regulate the fluid flow. It is typically made of metal and/or synthetic materials. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
DZI DRILL, BONE, POWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K043310 000
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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

9866f6ba-50a7-4d57-b935-0b49fee8173c
April 18, 2022
6
June 30, 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
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H679050010710
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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
07611819168091
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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