FDA.reportPublic FDA data

TSI

Primary DI
00843059113358
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
ML-0342
Device description
PEDICLE SCREW PROBE, STERILE, 10/BOX
Published
2017-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843059113358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843059113358008430591133588430591133580843059113358

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
00843059126945MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00843059126990MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00190376509747SafeOp 3ALPHATEC SPINE, INC.PDQ2026-03-24
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00190376517506SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-08-23
00190376549392SafeOp 3ALPHATEC SPINE, INC.PDQ2024-07-12
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
10705034604527TELIGENMedos International SàrlPDQ2024-02-10
00195377153951PULSENuvasive, Inc.PDQ2023-07-11
00195377153968PULSENuvasive, Inc.PDQ2023-07-11
00195377153975PULSENuvasive, Inc.PDQ2023-07-11
00195377060761PULSENuvasive, Inc.PDQ2023-07-06
00195377060778PULSENuvasive, Inc.PDQ2023-07-06
00195377099013PULSENuvasive, Inc.PDQ2023-07-06
00195377153807PULSENuvasive, Inc.PDQ2023-05-02
00195377153814PULSENuvasive, Inc.PDQ2023-05-02
00195377097422NVM5Nuvasive, Inc.PDQ2023-04-13
00195377097439NVM5Nuvasive, Inc.PDQ2023-04-13