DEVICE: Clearview Black Belt Retractor Starter Set (10840199501721)
Device Identifier (DI) Information
Clearview Black Belt Retractor Starter Set
7319-98T
In Commercial Distribution
7319-98T
KOROS U.S.A., INC.
7319-98T
In Commercial Distribution
7319-98T
KOROS U.S.A., INC.
Clearview Black Belt Retractor Starter Set Consists of the Following:
Black Finish Stainless Steel Retractor Frames and Blue Finish Titanium Blades.
1x 7320-22T - Retractor frame Right
1x 7320-30T - Retractor frame Offset
2x 7320-40T - Blade Inserting Angled Clamps
2x 7322-34T - Pronged Blade Ti 34 mm,
2x 7322-40T - Pronged Blade Ti 40 mm,
2x 7322-45T - Pronged Blade Ti 45 mm,
2x 7322-50T - Pronged Blade Ti 50 mm,
2x 7322-55T - Pronged Blade Ti 55 mm,
2x 7322-60T - Pronged Blade Ti 60 mm,
2x 7324-34T - Blunt Blade Ti 34 mm,
2x 7324-40T - Blunt Blade Ti 40 mm,
2x 7324-45T - Blunt Blade Ti 45 mm,
2x 7324-50T - Blunt Blade Ti 50 mm,
2x 7324-55T - Blunt Blade Ti 55 mm,
2x 7324-60T - Blunt Blade Ti 60 mm,
1x 7319-90T - Sterilizing Instrument Case, 1.5 x 11 x 13"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
45182 | Self-retaining surgical retractor, reusable |
A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZT | Retractor, Self-Retaining, For Neurosurgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K935529 | 000 |
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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No Device Sizes |
Device Record Status
37b44e79-b497-4850-8342-77b7daae0bd9
July 06, 2021
1
June 28, 2021
July 06, 2021
1
June 28, 2021
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