FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569660741
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC1280
Catalog number
ANC1280
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569660741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569660741037005696607413700569660741

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04