FDA.reportPublic FDA data

SCARLET® AC-Ti

Primary DI
07640332478462
Brand
SCARLET® AC-Ti
Company
SpineArt SA
Model
SCA-IC 33 00-N
Catalog number
SCA-IC 33 00-N
Device description
TRIAL HOLDER
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWRDriver, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640332478462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640332478462076403324784627640332478462

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
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
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
G079C5080000160MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
09348215083069Dual Mobility Sleeve DriverSIGNATURE ORTHOPAEDICS PTY LTDHWR2023-01-27
G079C5070000030Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2022-09-23
10603295547631INHANCEDEPUY (IRELAND)HWR2022-05-16
10603295538912INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295538943INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539339INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539353INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539391INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539476INHANCEDEPUY (IRELAND)HWR2021-08-30
10705034371856N/ADEPUY SPINE, LLCHWR2019-02-01
10603295094869NADEPUY ORTHOPAEDICS, INC.HWR2018-09-24
10603295142720AGILITYDEPUY ORTHOPAEDICS, INC.HWR2018-09-24
10603295171904S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171911S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171928S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171935S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171942S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171959S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171966S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295215868P.F.C.DEPUY (IRELAND)HWR2018-09-24
10603295240730CHARNLEYDEPUY INTERNATIONAL LTDHWR2018-09-24
10603295240990CHARNLEYDEPUY INTERNATIONAL LTDHWR2018-09-24
10603295243311NADEPUY INTERNATIONAL LTDHWR2018-09-24