FDA.reportPublic FDA data

SharkCut

Primary DI
08800053401616
Brand
SharkCut
Company
Techcord co.,Ltd
Model
RB2650
Catalog number
RB2650
Device description
Shaver Blade_OD 5.0 WL 128 Round Burr Stryker Type
Published
2024-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053403375PackageGS15In Commercial Distribution
08800053401616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053403375088000534033758800053403375
08800053401616088000534016168800053401616

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, single-useA cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length128Millimeter
Outer Diameter5Millimeter

Contacts#

Phone, Email table
PhoneEmail
+82422210015dongdongil@techcord.co.kr

Regulatory Flags#

DUNS number
688890630
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800053402149SharkCutTSS1930DTSS1930D2024-05-02
08800053402156SharkCutTSS1940DTSS1940D2024-05-02
08800053402163SharkCutTSL1930DTSL1930D2024-05-02
08800053402170SharkCutTSL1940DTSL1940D2024-05-02
08800053402187SharkCutTSN1930DTSN1930D2024-05-02
08800053402194SharkCutTSN1940DTSN1940D2024-05-02
08800053403962SharkCutTSS1930DTSS1930D2024-05-02
08800053403979SharkCutTSS1940DTSS1940D2024-05-02
08800053403986SharkCutTSL1930DTSL1930D2024-05-02
08800053403993SharkCutTSL1940DTSL1940D2024-05-02
08800053404006SharkCutTSN1930DTSN1930D2024-05-02
08800053404013SharkCutTSN1940DTSN1940D2024-05-02
08800053401531SharkCutT2850T28502024-04-16
08800053401548SharkCutT2855T28552024-04-16
08800053401586SharkCutT2950T29502024-04-16
08800053401593SharkCutT2955T29552024-04-16
08800053401623SharkCutRB2730RB27302024-04-16
08800053401647SharkCutRB2750RB27502024-04-16
08800053401654SharkCutRB2830RB28302024-04-16
08800053401678SharkCutRB2850RB28502024-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401531SharkCutTechcord co.,LtdGFA2024-04-16
08800053401548SharkCutTechcord co.,LtdGFA2024-04-16
08800053401586SharkCutTechcord co.,LtdGFA2024-04-16
08800053401593SharkCutTechcord co.,LtdGFA2024-04-16
08800053401623SharkCutTechcord co.,LtdGFA2024-04-16
08800053401647SharkCutTechcord co.,LtdGFA2024-04-16
08800053401654SharkCutTechcord co.,LtdGFA2024-04-16
08800053401678SharkCutTechcord co.,LtdGFA2024-04-16
08800053401692SharkCutTechcord co.,LtdGFA2024-04-16
08800053401708SharkCutTechcord co.,LtdGFA2024-04-16
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401340SharkCutTechcord co.,LtdGFA2024-04-15
08800053401357SharkCutTechcord co.,LtdGFA2024-04-15