FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569628307
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC1146
Catalog number
ANC1146
Published
2024-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569628307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569628307037005696283073700569628307

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569658212Xpert PFPFT5.6D-STFT5.6D-ST2026-06-03
00370056966385Xpert PFPQTDE1D-STQTDE1D-ST2026-06-02
03700569658151Xpert PFPQTDP-E1D-STQTDP-E1D-ST2026-06-02
03700569658175Xpert PFPQTDP-E2D-STQTDP-E2D-ST2026-06-02
03700569658199Xpert PFPQTGPH2D-STQTGPH2D-ST2026-06-02
03700569662202Xpert PFPQTSM1D-STQTSM1D-ST2026-06-02
03700569663247Xpert PFPQTDE2D-STQTDE2D-ST2026-06-02
03700569663841Xpert PFPQTGE2D-STQTGE2D-ST2026-06-02
03700569663865Xpert PFPQTDE3D-STQTDE3D-ST2026-06-02
03700569663872Xpert PFPQTDP1D-STQTDP1D-ST2026-06-02
03700569663889Xpert PFPQTDP2D-STQTDP2D-ST2026-06-02
03700569663896Xpert PFPQTDP3D-STQTDP3D-ST2026-06-02
03700569663902Xpert PFPQTGP3D-STQTGP3D-ST2026-06-02
03700569663919Xpert PFPQTGP2D-STQTGP2D-ST2026-06-02
03700569663926Xpert PFPQTGP1D-STQTGP1D-ST2026-06-02
03700569663933Xpert PFPQTGE1D-STQTGE1D-ST2026-06-02
03700569663940Xpert PFPQTGE3D-STQTGE3D-ST2026-06-02
03700569663964Xpert PFPQTSM3D-STQTSM3D-ST2026-06-02
03700569671327Xpert PFPQTGP-E1D-STQTGP-E1D-ST2026-06-02
03700569676438Xpert PFPQTDPH1D-STQTDPH1D-ST2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
00822409135721N/AOrtho Development CorporationHWA2026-07-16
07630055307781Positioning handle - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307798Positioning handle - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
07630055307804Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
00840286860406Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWA2026-07-09
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
08809885739751PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.HWA2026-01-28
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07630055302458Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2020-04-23
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10