FDA.reportPublic FDA data

Clear View Black Belt Extended Retractor System

Primary DI
00840199501885
Brand
Clear View Black Belt Extended Retractor System
Company
KOROS U.S.A., INC.
Model
7320-05T
Catalog number
7320-05T
Device description
"Radiolucent ClearView Black Belt Extended Retractor Set Consists of the Following: Set consists of: 1 7320-22T 1 ea Korpectomy Retractor Frame, Right 2 7320-20T 1 ea Retractor Frame, Left 3 7320-30T 1 ea Retractor Frame, Offset 4 7320-40T 2 ea Blade Inserting Clamps 5 7322-34T thru 70T 2 ea Pronged Ti Blades (14 total) 6 7324-34T thru 70T 2 ea Blunt Ti Blades (14 total) 7 7326-40T,-47T,-55T 4 ea Two-Level Ti Blades, Pronged 8 7328-40T,-47T,-55T 2 ea Two-Level Ti Blades, Blunt 9 7320-90T 1 ea Sterilizing Instrument Case with silicone inserts. 10 7321-10M 1 ea Microdiscectomy Adaptor 11 7321-20T 1 ea Spike Blade, 70 mm 12 7321-30T 1 ea T-Shape Blade, 70 mm 13 7321-40T 1 ea Inner Spine Ligament Blade, 70 mm 14 7322-85T 1 ea Pronged Ti Blade, 22x85 mm 15 7322-75T 1 ea 15 cm long Retractor Rack"
Published
2024-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935529000CERVICAL SELF-RETAINING RETRACTORT. Korossurgical Instruments Corp.1994-03-22GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199501885Direct MarkingGS10
10840199501882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199501885008401995018858401995018850840199501885
1084019950188210840199501882

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10840199531056Impactor7585-027585-022022-03-01
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00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

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