FDA.report

Newclip Instruments

Primary DI
03700569652937
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC1159
Catalog number
ANC1159
Published
2024-11-07
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

Related Records

Product Codes

CodeName
HXPInstrument, Bending Or Contouring

Product Code Classifications

CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700569652937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700569652937037005696529373700569652937

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

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 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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