DEVICE: Coughlin Instrument Set (10840199543813)
Device Identifier (DI) Information
Coughlin Instrument Set
7449-15
In Commercial Distribution
7449-15
KOROS U.S.A., INC.
7449-15
In Commercial Distribution
7449-15
KOROS U.S.A., INC.
Coughlin Instrument Set Consists of the Following:
1 x 7449-16, 1 x 7449-17, 1 x 7449-18, 1 x 7449-19, 1 x 7449-20, 1 x 7449-21, 1 x 7449-22, 1 x 7449-23, 1 x 7449-24, 1 x 7449-25, 1 x 7449-26, 1 x 7449-27, 1 x 7449-28, 1 x 7449-29, 1 x 7449-30, 1 x 7449-31 & 1 x 7449-32
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 |
12844 | Orthopaedic osteotome |
A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
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Active | false |
35090 | Surgical gouge |
A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FZS | Curette, Surgical, General Use |
EMM | Chisel, Osteotome, Surgical |
GAH | Stylet, Surgical, General & Plastic Surgery |
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
4e0df187-3880-407a-b4d0-d67bcdf769a7
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 |
---|---|---|---|---|---|
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