FDA.reportPublic FDA data

SharkCut

Primary DI
08800053403979
Brand
SharkCut
Company
Techcord co.,Ltd
Model
TSS1940D
Catalog number
TSS1940D
Device description
Shaver Blade_OD 4.0 WL 131 Diamond Burr Stryker 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
08800053403979PackageGS15In Commercial Distribution
08800053402156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053403979088000534039798800053403979
08800053402156088000534021568800053402156

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
Length131Millimeter
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
08800053403986SharkCutTSL1930DTSL1930D2024-05-02
08800053403993SharkCutTSL1940DTSL1940D2024-05-02
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
B504OM22963414S70StrykerProvisionGFA2026-07-20
B504OM41251470900StrykerProvisionGFA2026-07-20
B504OM50711850Conmed LinvatecProvisionGFA2026-07-20
B504OM51003372330StrykerProvisionGFA2026-07-20
47630055517706Short Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517737Short Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517768Long Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517799Long Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519212Short Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519243Long Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
17630055512236Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512243Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512250Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512267Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512274Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512281Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512298Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512304Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512311Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512328Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512335Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512342Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512359Short Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512366Short Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2023-02-17