DEVICE: Cervical SL5 Micro Curette Set (10840199543776)

Device Identifier (DI) Information

Cervical SL5 Micro Curette Set
7420-00
In Commercial Distribution
7420-00
KOROS U.S.A., INC.
10840199543776
GS1

1
007928633 *Terms of Use
Cervical SL5 Micro Curette Set Consists of the Following: 1 x 7420-80, 4 x 7420-60, 1 x 7420-50, 1 x 7420-40, 1 x 7420-30, 1 x 7420-20, 1 x 7420-10, 1 x 7422-60, 1 x 7422-50, 1 x 7422-40, 1 x 7422-30, 1 x 7424-20, 1 x 7424-10 & 1 x 7420-90
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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?
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.
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.
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZS Curette, Surgical, General Use
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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
Special Storage Condition, Specify: Store in dry place at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 3mm tip
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Device Record Status

98c85188-994f-4a84-88ab-3cf318bfa052
November 08, 2022
1
October 31, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
00840199543779
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
1-805-529-0825
customerservice@korosUSA.com
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