DEVICE: DISTRACTION, INTERNAL (00888118081506)

Device Identifier (DI) Information

DISTRACTION, INTERNAL
51-500-91-07
In Commercial Distribution

KLS-Martin L.P.
00888118081506
GS1

1
826499238 *Terms of Use
PATIENT SCREWDRIVER, HEX, ZURICH, GOLD
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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?
64610 Implantable craniofacial bone distractor expansion tool, home-use
A hand-held, manual device intended to be used by a layperson to adjust an intraoral implantable craniofacial bone distractor to progressively lengthen the distractor, typically during expansion of the maxilla. It is used by the patient in the home for daily, gradual distraction. This is a single-patient reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HXX SCREWDRIVER
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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
Device Size Text, specify: 2.5 MM HEX
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Device Record Status

803be970-1103-40fc-9ec2-14d328193a18
August 26, 2024
5
September 26, 2018
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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
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(904)641-7746
KLS-UDI-Info@klsmartin.com
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