FDA.reportPublic FDA data

TSI

Primary DI
00843059108644
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
CS-1730C
Device description
CONICAL DELTA STYLE BLADE, 30 MM, TITANIUM
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843059108644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843059108644008430591086448430591086440843059108644

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
791619393
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
00843059126945MedtronicMDT-0442S2026-04-28
00843059126969MedtronicMDT-0459S2026-04-28
00843059126990MedtronicMDT-0469S2026-04-28
008430591217353CorD-00122018-08-09
008430591217593CorD-00162018-08-09
00843059121797LDR Spine USA0022LDR2018-08-09
00843059121803LDR Spine USA0024LDR2018-08-09
00843059125979TSIUL-0360SUL-0360S-052022-07-15
00843059125986TSIUL-0362SUL-0362S-052022-07-15
00843059125993TSIUL-0364SUL-0364S-052022-07-15
00843059126006TSIUL-0366SUL-0366S-052022-07-15
00843059126013TSIUL-0368SUL-0368S-052022-07-15
00843059126020TSIUL-0370SUL-0370S-052022-07-15
00843059126037TSIUL-0372SUL-0372S-052022-07-15
00843059126044TSIUL-0374SUL-0374S-052022-07-15
00843059126051TSIUL-0376SUL-0376S-052022-07-15
00843059126068TSIUL-0378SUL-0378S-052022-07-15
00851797006443TSIDS-00122017-05-22
00851797006450TSIDS-00142017-05-22
00851797006467TSIDS-00162017-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701109Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701116ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701123ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701130ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701147ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701154ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701161ArtiSential Precise DissectorLIVSMEDMDM2026-04-29