DEVICE: Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® (14053613290767)

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Device Record History
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Device Identifier (DI) Information
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall®
CC254-119-90F
In Commercial Distribution
CC254-119-90F
Gebr. Brasseler GmbH & Co. KG
14053613290767
GS1

1
317409001 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
43376 Surgical saw blade, sagittal, single-use
A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use 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
Yes
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
23b07ad4-7f7c-41a8-8df5-649350efe10b
November 19, 2024
1
November 11, 2024
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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
24053613290764 5 14053613290767 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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