FDA.reportPublic FDA data

ANTHEM

Primary DI
00193982339876
Brand
ANTHEM
Company
GLOBUS MEDICAL, INC.
Model
1181.4224
Device description
Non-Locking Screw, 1.5 x 24mm, Ti
Published
2021-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982339876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982339876001939823398761939823398760193982339876

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
00193982586430CAPTIVATE3188.25153188.25152026-06-10
00193982586454CAPTIVATE3188.25173188.25172026-06-10
00193982586478CAPTIVATE3188.25193188.25192026-06-10
00193982586690CAPTIVATE3188.26143188.26142026-06-10
00193982586706CAPTIVATE3188.26153188.26152026-06-10
00193982586713CAPTIVATE3188.26163188.26162026-06-10
00193982586720CAPTIVATE3188.26173188.26172026-06-10
00193982586737CAPTIVATE3188.26183188.26182026-06-10
00193982586744CAPTIVATE3188.26193188.26192026-06-10
00193982586973CAPTIVATE3188.30113188.30112026-06-10
00193982586997CAPTIVATE3188.30133188.30132026-06-10
00193982587017CAPTIVATE3188.30153188.30152026-06-10
00193982587031CAPTIVATE3188.30173188.30172026-06-10
00193982587055CAPTIVATE3188.30193188.30192026-06-10
00193982587277CAPTIVATE3188.31143188.31142026-06-10
00193982587284CAPTIVATE3188.31153188.31152026-06-10
00193982587291CAPTIVATE3188.31163188.31162026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894822858APTUSMedartis AGHRS2026-07-16
07630894822865APTUSMedartis AGHRS2026-07-16
07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16