FDA.reportPublic FDA data

Target Endoscopic Instrument

Primary DI
08800147701837
Brand
Target Endoscopic Instrument
Company
SOLENDOS Inc.
Model
TMP0002
Device description
[Target] TMP0002 Micro Pituitary 2.0mm Up
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800147701837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800147701837088001477018378800147701837

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
08800147700878Target Endoscopic InstrumentTCU00052024-12-09

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Primary DI, Brand, Company table
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00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
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G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
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