FDA.reportPublic FDA data

TSI

Primary DI
00843059125979
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
UL-0360S
Catalog number
UL-0360S-05
Device description
ATP Screw, 60 MM, Sterile, 5/Box
Published
2022-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10843059125976PackageGS15In Commercial Distribution
00843059125979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084305912597610843059125976
00843059125979008430591259798430591259790843059125979

GMDN Terms#

Term, Definition table
TermDefinition
Spinal intraoperative positioning/manipulation pin, single-useA nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded; however, as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a single-use device.

Regulatory Flags#

DUNS number
791619393
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843059127188LattusLAT-20062026-07-20
00843059127195LattusLAT-20072026-07-20
00843059127201LattusLAT-21202026-07-20
00843059127218LattusLAT-31202026-07-20
00843059127225LattusLAT-40902026-07-20
00843059127232LattusLAT-41002026-07-20
00843059127249LattusLAT-41102026-07-20
00843059127256LattusLAT-41202026-07-20
00843059127263LattusLAT-41302026-07-20
00843059127270LattusLAT-41402026-07-20
00843059127287LattusLAT-41502026-07-20
00843059127294LattusLAT-41602026-07-20
00843059127300LattusLAT-41702026-07-20
00843059127317LattusLAT-41802026-07-20
00843059127331LattusLAT-15632026-07-20
00843059127348LattusLAT-15312026-07-20
00843059127355LattusLAT-15322026-07-20
00843059127379LattusLAT-15042026-07-20
00843059127386LattusLAT-05142026-07-20
00843059127393LattusLAT-15152026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25