FDA.reportPublic FDA data

TSI

Primary DI
00843059112320
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
ML-0044
Device description
RACK CLAMP, QUICK CONNECT
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843059112320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843059112320008430591123208430591123200843059112320

GMDN Terms#

Term, Definition table
TermDefinition
Medical table clampA device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. 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
00696588008370MorphBoard®Innovative Medical Products, IncFWZ2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
00696588008318De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
00810014600598SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600666SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600833SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014602714SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
07640152573989FISSOBaitella AGFWZ2025-10-13
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28