DEVICE: KOMET Surgical Saw Blade (14053613275092)

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Device Record History
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Device Identifier (DI) Information
KOMET Surgical Saw Blade
KM71278.C00..K2
In Commercial Distribution
KM71278.C00.
Gebr. Brasseler GmbH & Co. KG
14053613275092
GS1

1
317409001 *Terms of Use
No description.
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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?
44986 Sternum saw blade, reusable
A flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GFA BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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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
04c5bb1a-562b-4d6f-a389-10c86854d03e
February 09, 2023
1
February 01, 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
24053613275099 5 14053613275092 In Commercial Distribution
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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
Yes
04053613275095
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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