DEVICE: Rhoton Spetzler Type Set (10840199544223)

Device Identifier (DI) Information

Rhoton Spetzler Type Set
7793-00
In Commercial Distribution
7793-00
KOROS U.S.A., INC.
10840199544223
GS1

1
007928633 *Terms of Use
Rhoton Spetzler Type Titanium Set Consists of the Following: 1 x 7793-01, 1 x 7793-02, 1 x 7793-03, 1 x 7793-04, 1 x 7793-05, 1 x 7793-06, 1 x 7793-07, 1 x 7793-08, 1 x 7793-09, 1 x 7793-10, 1 x 7793-11, 1 x 7793-12, 1 x 7793-13, 1 x 7793-15, 1 x 7793-15, 1 x 7793-16, 1 x 7793-17, 1 x 7793-18, 1 x 7793-19, 1 x 7793-20, 1 x 7793-21, 1 x 7793-22 & 1 x 7793-23
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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?
11290 Open-surgery dissector
A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.
Active false
35559 Bone file/rasp, manual, reusable
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Active false
42595 Soft-tissue surgical hook, reusable
A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GDI Dissector, Surgical, General & Plastic Surgery
LXC Monitor, Pressure, Intracompartmental
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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: 9x12mm
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Device Record Status

489c6cf1-b68f-47fd-a2d0-01de82e4c2ef
January 09, 2023
1
December 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
00840199544226
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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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