FDA.reportPublic FDA data

SharkCut

Primary DI
08800053403993
Brand
SharkCut
Company
Techcord co.,Ltd
Model
TSL1940D
Catalog number
TSL1940D
Device description
Shaver Blade_OD 4.0 WL 134 Diamond Burr Linvatec Type
Published
2024-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
08800053403993PackageGS15In Commercial Distribution
08800053402170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053403993088000534039938800053403993
08800053402170088000534021708800053402170

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
Length134Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688890630
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08800053404006SharkCutTSN1930DTSN1930D2024-05-02
08800053404013SharkCutTSN1940DTSN1940D2024-05-02
08800053401531SharkCutT2850T28502024-04-16
08800053401548SharkCutT2855T28552024-04-16
08800053401586SharkCutT2950T29502024-04-16
08800053401593SharkCutT2955T29552024-04-16
08800053401616SharkCutRB2650RB26502024-04-16
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
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