FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569623173
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC568
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
03700569623173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569623173037005696231733700569623173

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569660000KEMISANC2092025-12-10
03700569660017KEMISANC11032025-12-10
0340042000005006082025GUDIDSync2.00106082025GUDIDSync22025-08-14
0340042000002915072025GUDIDSync115072025GUDIDSync12025-08-12
03700569604233Alians ClavicleQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257Alians ClavicleQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271Alians ClavicleQOT3.5L14-STQOT3.5L14-ST2024-11-15
03700569604295Alians ClavicleQOT3.5L16-STQOT3.5L16-ST2024-11-15
03700569604318Alians ClavicleQOT3.5L18-STQOT3.5L18-ST2024-11-15
03700569604332Alians ClavicleQOT3.5L20-STQOT3.5L20-ST2024-11-15
03700569604356Alians ClavicleQOT3.5L22-STQOT3.5L22-ST2024-11-15
03700569604370Alians ClavicleQOT3.5L24-STQOT3.5L24-ST2024-11-15
03700569604394Alians ElbowQOT3.5L26-STQOT3.5L26-ST2024-11-15
03700569604400Alians ElbowQOT3.5L28QOT3.5L282024-11-15
03700569604417Alians ElbowQOT3.5L28-STQOT3.5L28-ST2024-11-15
03700569604424Alians ElbowQOT3.5L30QOT3.5L302024-11-15
03700569604431Alians ElbowQOT3.5L30-STQOT3.5L30-ST2024-11-15
03700569604448Alians ElbowQOT3.5L32QOT3.5L322024-11-15
03700569604455Alians ElbowQOT3.5L32-STQOT3.5L32-ST2024-11-15
03700569604462Alians ElbowQOT3.5L34QOT3.5L342024-11-15

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Primary DI, Brand, Company table
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03662663136709Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136723Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
00888867531659Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531666Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531673Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531697Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531703Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531710Arthrex®ARTHREX, INC.HTO2026-03-16
00843575120205Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
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00843575120243Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120250Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120267Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120274Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
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