FDA.reportPublic FDA data

Arthrex Bone Cement Syringe Gun, Disposable

Primary DI
08058964729071
Brand
Arthrex Bone Cement Syringe Gun, Disposable
Company
G21 SRL
Model
AS-901-4
Published
2024-10-14
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
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
28058964729075PackageGS125In Commercial Distribution
08058964729071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2805896472907528058964729075
08058964729071080589647290718058964729071

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431529195
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
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G9000302026-05-05
08058964729057Arthrex Bone Cement Closed Mixing Bowl AS-901-22024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe AS-901-32024-10-14
08058964727862SpaceFlex Knee Trial9002012024-10-10
08058964728654Arthrex Bone Cement Mixing Syringe AR-901-32024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlAR-901-12024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl AR-901-22024-10-14
08058964728760Arthrex Bone Cement Syringe Gun, DisposableAR-901-42024-10-14
08058964729217CeMend Shoulder SpacerAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerAR-902-10482025-12-19
08058964729248CeMend Shoulder SpacerAR-902-12482025-12-19
08058964729255CeMend Shoulder Spacer Reamer TrayAR-902-C12025-12-19
08058964729262Reamer T-handleAR-902-132025-12-19
08058964729279CeMend Reamer 8mmAR-902-142025-12-19
08058964729286CeMend Reamer 10mmAR-902-152025-12-19
08058964729293CeMend Reamer 12mmAR-902-162025-12-19
08058964729309CeMend Reamer 14mmAR-902-172025-12-19
08058964729385CeMend Shoulder Spacer Trial 08 42AR-902-202025-12-19
08058964729392CeMend Shoulder Spacer Trial 10 42AR-902-212025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09