FDA.reportPublic FDA data

SCARLET AL-T INSTRUMENTATION

Primary DI
07640185340015
Brand
SCARLET AL-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IN 07 00-N
Catalog number
SCA-IN 07 00-N
Device description
COMPACTION BASE
Published
2018-12-07
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640185340015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640185340015076401853400157640185340015

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. 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
07640139342287Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 08-SDYN-BS 22 08-S2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 10-SDYN-BS 22 10-S2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 12-SDYN-BS 22 12-S2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 14-SDYN-BS 22 14-S2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 16-SDYN-BS 22 16-S2018-03-12
07640151087500BGran® Synthetic Osteoconductive ScaffoldBGS-005BGS-0052017-09-18
07640151087517BGran® Synthetic Osteoconductive ScaffoldBGS-010BGS-0102017-09-18
07640151087524BGran® Synthetic Osteoconductive ScaffoldBGS-015BGS-0152017-09-18
07640151087531BGran® Synthetic Osteoconductive ScaffoldBGS-030BGS-0302017-09-18
07640151087654BGran® Synthetic Osteoconductive ScaffoldBGF-001BGF-0012017-09-18
07640151087661BGran® Synthetic Osteoconductive ScaffoldBGF-005BGF-0052017-09-18
07640151087678BGran® Synthetic Osteoconductive ScaffoldBGF-010BGF-0102017-09-18
07640151087685BGran® Synthetic Osteoconductive ScaffoldBGL-015BGL-0152017-09-18
07640151087692BGran® Synthetic Osteoconductive ScaffoldBGL-030BGL-0302017-09-18
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21

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