FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569617745
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC599
Catalog number
ANC599
Published
2024-11-08
Public version status
New
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569617745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569617745037005696177453700569617745

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, single-useA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263281904
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
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
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00190376544502InvictusALPHATEC SPINE, INC.HTO2026-07-30
03701089526364AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526371AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526388AMPLITUDEAMPLITUDE SASHTO2026-07-29
03700569676636Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676643Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676650Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
18059015378320Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378337Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378344Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378351Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378399Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
10810128461426Back Drill 4.5 X 7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461440Back Drill 4.5 X 8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22