FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569676643
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC1750
Catalog number
ANC1750
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
03700569676643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569676643037005696766433700569676643

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.

Regulatory Flags#

DUNS number
263281904
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569631840Alians ForearmHTSIS2HTSIS22026-10-01
03700569631857Alians ForearmHTSIS2-STHTSIS2-ST2026-10-01
03700569633943NAQBT2.8L18-STQBT2.8L18-ST2026-10-01
03700569633967NAQBT2.8L20-STQBT2.8L20-ST2026-10-01
03700569633981NAQBT2.8L22-STQBT2.8L22-ST2026-10-01
03700569634001NAQBT2.8L24-STQBT2.8L24-ST2026-10-01
03700569634025NAQBT2.8L26-STQBT2.8L26-ST2026-10-01
03700569634049NAQBT2.8L28-STQBT2.8L28-ST2026-10-01
03700569634063NAQBT2.8L30-STQBT2.8L30-ST2026-10-01
03700569602918Alians ForearmETSIS1ETSIS12024-11-14
03700569602925Alians ForearmETSIS1-STETSIS1-ST2024-11-14
03700569602932Alians ForearmETSIS2ETSIS22024-11-14
03700569602949Alians ForearmETSIS2-STETSIS2-ST2024-11-14
03700569602956Alians ForearmETSIS3ETSIS32024-11-14
03700569602963Alians ForearmETSIS3-STETSIS3-ST2024-11-14
03700569602970Alians ForearmETSIS4ETSIS42024-11-14
03700569602987Alians ForearmETSIS4-STETSIS4-ST2024-11-14
03700569604233NAQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257NAQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271NAQOT3.5L14-STQOT3.5L14-ST2024-11-15

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
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00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592344TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592351TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592368TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592375TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592382TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592399TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006441CrossTIE™ Reamer 2.5mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006458CrossTIE™ Reamer 2.7mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006465CrossTIE™ Reamer 3.0mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00815432028641MotoBAND CP Reamer, 2.0mmCROSSROADS EXTREMITY SYSTEMSHTO2022-11-30