FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569648930
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC1105-2
Catalog number
ANC1105-2
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
HTZInstrument, Cutting, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569648930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569648930037005696489303700569648930

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
03700569621261Newclip InstrumentsANC306ANC3062026-05-11
03700569626181NACT2.8L60CT2.8L602024-11-14
03700569626198NACT2.8L60-STCT2.8L60-ST2024-11-14
03700569627553NACT3.5L38DCT3.5L38D2024-11-14
03700569628154NACT3.5L10D-STCT3.5L10D-ST2024-11-14
03700569628178NACT3.5L12D-STCT3.5L12D-ST2024-11-14
03700569628192NACT3.5L14D-STCT3.5L14D-ST2024-11-14
03700569628215NACT3.5L16D-STCT3.5L16D-ST2024-11-14
03700569628239NACT3.5L18D-STCT3.5L18D-ST2024-11-14
03700569628291NACT3.5L24D-STCT3.5L24D-ST2024-11-14
03700569628314NACT3.5L26D-STCT3.5L26D-ST2024-11-14
03700569644536NACT3.5L10DCT3.5L10D2024-11-14
03700569644543NACT3.5L12DCT3.5L12D2024-11-14
03700569644550NACT3.5L14DCT3.5L14D2024-11-14
03700569644567NACT3.5L16DCT3.5L16D2024-11-14
03700569644574NACT3.5L18DCT3.5L18D2024-11-14
03700569644604NACT3.5L24DCT3.5L24D2024-11-14
03700569647100NACT4.5L30D2024-11-14
03700569647117NACT4.5L30D-STCT4.5L30D-ST2024-11-14
03700569647124NACT4.5L35DCT4.5L35D2024-11-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
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10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
00196449033454Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033461Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033591Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033676Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034192Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
B471293000100GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
10886982339492NASynthes GmbHHTZ2024-10-09
10887587077611NASynthes GmbHHTZ2024-08-21
07898506814107QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814114QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841677QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841691QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841707QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841714QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841752QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506848959QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849413QuinelatoSchobell Industrial LtdaHTZ2023-01-10