FDA.reportPublic FDA data

Target Endoscopic Instrument

Primary DI
08800147701103
Brand
Target Endoscopic Instrument
Company
SOLENDOS Inc.
Model
TRR0001
Device description
[Target] TRR0001 Root Retractor
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800147701103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800147701103088001477011038800147701103

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437169MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776439781MilleniumAvalign Technologies, Inc.GAD2026-10-26
00190776436957MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437015MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437022MillenniumAvalign Technologies, Inc.GAD2026-10-23
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16