DEVICE: BladeCARTRIDGE-1 (19337363001466)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
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46236 | Scalpel blade remover, sterile |
A sterile device used to safely remove and contain one scalpel blade from a reusable scalpel handle without compromising the sterility of a surgical field. It is typically a sealed plastic cartridge into which a scalpel is pushed, and where an internal configuration transforms this linear motion into a lateral force that lifts the heel (rear portion) of the scalpel blade from the tang of the handle, and a reverse linear motion (pulling the scalpel handle out) removes the blade from the tang; the blade is retained within the container. This device may have a dedicated holder and is typically used in surgical facilities. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GES | Blade, Scalpel |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7c0d9db2-75c1-46d1-891f-905db739f4d1
March 29, 2018
2
August 22, 2017
March 29, 2018
2
August 22, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
29337363001463 | 4 | 19337363001466 | In Commercial Distribution | Outer Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
09337363001469
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined