DEVICE: Lumbar Micro-Bayonet Curette Set (10840199543769)
Device Identifier (DI) Information
Lumbar Micro-Bayonet Curette Set
7419-00
In Commercial Distribution
7419-00
KOROS U.S.A., INC.
7419-00
In Commercial Distribution
7419-00
KOROS U.S.A., INC.
Lumbar Micro-Bayonet Curette Set Consists of the Following:
1 x 7419-10, 1 x 7419-12, 1 x 7419-20, 1 x 7419-21, 1 x 7419-22, 1 x 7419-30, 1 x 7419-31, 1 x 7419-32, 1 x 7419-40, 1 x 7419-41, 1 x 7419-42, 1 x 7419-50, 1 x 7419-51, 1 x 7419-52, 1 x 7419-60, 1 x 7419-61, 1 x 7419-71, 1 x 7419-72, 1 x 7419-73, 1 x 7419-74, 1 x 7419-80, 1 x 7419-82 & 2 x 7419-95
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
62558 | General-purpose curette |
A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.
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Active | false |
31335 | Bone curette, reusable |
A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.
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Active | false |
32772 | Ophthalmic curette, reusable |
A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FZS | Curette, Surgical, General Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dry place at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3mm tip |
Device Record Status
b8f4f273-10da-46d8-bd66-0b028529c060
November 08, 2022
1
October 31, 2022
November 08, 2022
1
October 31, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-805-529-0825
customerservice@korosUSA.com
customerservice@korosUSA.com