FDA.reportPublic FDA data

Multi Level BB Blunt Blade

Primary DI
10840199513694
Brand
Multi Level BB Blunt Blade
Company
KOROS U.S.A., INC.
Model
7325-60
Catalog number
7325-60
Device description
Multi Level Black Belt Blunt Blade 55mm Standard Width, Aluminum
Published
2021-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199513697Direct MarkingGS10
10840199513694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199513697008401995136978401995136970840199513697
1084019951369410840199513694

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth90Millimeter
Width22Millimeter

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
Lot or batch
true
Serial number
true
Sterilization required before use
true

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Primary DI, Brand, Company table
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