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.
7793-00
In Commercial Distribution
7793-00
KOROS U.S.A., INC.
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
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GDI | Dissector, Surgical, General & Plastic Surgery |
LXC | Monitor, Pressure, Intracompartmental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dry place at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 9x12mm |
Device Record Status
489c6cf1-b68f-47fd-a2d0-01de82e4c2ef
January 09, 2023
1
December 31, 2022
January 09, 2023
1
December 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 |
---|---|
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