FDA.reportPublic FDA data

Target Endoscopic Instrument

Primary DI
08800147700878
Brand
Target Endoscopic Instrument
Company
SOLENDOS Inc.
Model
TCU0005
Device description
[Target] TCU0005 Reverse Curette 3.0mm
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800147700878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800147700878088001477008788800147700878

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+082269566541ksc@solendos.com

Regulatory Flags#

DUNS number
688020606
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800147702636IRIS ArthroscopeTA240-1702025-01-07
08800147702643IRIS ArthroscopeTA240-1002025-01-07
08800147702650IRIS ArthroscopeTA340-1702025-01-07
08800147702667IRIS ArthroscopeTA340-1302025-01-07
08800147702674IRIS ArthroscopeTA240-1302025-01-07
08800147702681IRIS ArthroscopeTA340-1002025-01-07
08800147702810IRIS ArthroscopeTA127-1002025-01-07
08800147702827IRIS ArthroscopeTA127-1302025-01-07
08800147702834IRIS ArthroscopeTA119-1002025-01-07
08800147702841IRIS ArthroscopeTA119-1302025-01-07
08800147701202Target Endoscopic InstrumentTST0001-12024-12-12
08800147701219Target Endoscopic InstrumentTST0001-22024-12-12
08800147701226Target Endoscopic InstrumentTSD00012024-12-12
08800147701240Target Endoscopic InstrumentTSD0001-22024-12-12
08800147701257Target Endoscopic InstrumentTSD0001-32024-12-12
08800147700823Target Endoscopic InstrumentTML00012024-12-09
08800147700830Target Endoscopic InstrumentTCU00032024-12-09
08800147700847Target Endoscopic InstrumentTCU00022024-12-09
08800147700861Target Endoscopic InstrumentTCU00042024-12-09
08800147700885Target Endoscopic InstrumentTCU00062024-12-09

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