FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569620509
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC221
Catalog number
ANC221
Published
2026-05-07
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
03700569620509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569620509037005696205093700569620509

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

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
00370056966354NARDT2.8L38D-STRDT2.8L38D-ST2026-07-28
03700569628253NACT3.5L20D-STCT3.5L20D-ST2026-07-28
03700569628277NACT3.5L22D-STCT3.5L22D-ST2026-07-28
03700569641269NAH1.3GLT4.0L70DH1.3GLT4.0L70D2026-07-28
03700569644451NASOT3.5L10DSOT3.5L10D2026-07-28
03700569644468NASOT3.5L12DSOT3.5L12D2026-07-28
03700569644475NASOT3.5L14DSOT3.5L14D2026-07-28
03700569644482NASOT3.5L16DSOT3.5L16D2026-07-28
03700569644499NASOT3.5L18DSOT3.5L18D2026-07-28
03700569644505NASOT3.5L20DSOT3.5L20D2026-07-28
03700569644512NASOT3.5L22DSOT3.5L22D2026-07-28
03700569644529NASOT3.5L24DSOT3.5L24D2026-07-28
03700569644581NACT3.5L20DCT3.5L20D2026-07-28
03700569644598NACT3.5L22DCT3.5L22D2026-07-28
03700569644611NACT3.5L26DCT3.5L26D2026-07-28
03700569652555NACT3.5L32DCT3.5L32D2026-07-28
03700569654757NACT3.5L40DCT3.5L40D2026-07-28
03700569657727NACT2.8L16DCT2.8L16D2026-07-28
03700569657963NACT2.8L40DCT2.8L40D2026-07-28
03700569659219Alians Elbow SNTGY1DNTGY1D2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407520MillenniumAvalign Technologies, Inc.HTZ2026-07-31
03701089527491AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527507AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527514AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527521AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527583AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527590AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527606AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527682AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527699AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527705AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527712AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527729AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527736AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527743AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527750AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527767AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527774AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527781AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527798AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527804AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527811AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527828AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527835AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527842AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527859AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089540780AMPLITUDEAMPLITUDE SASHTZ2026-07-29
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
M697X07901151Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.HTZ2026-07-08
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18