FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569622466
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
KIT-RESCUE-4
Catalog number
KIT-RESCUE-4
Published
2024-11-14
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569622466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569622466037005696224663700569622466

GMDN Terms#

Term, Definition table
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 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
03700569605063Newclip InstrumentsANC841ANC8412026-05-12
03700569605070Newclip InstrumentsANC843ANC8432026-05-12
03700569605087Newclip InstrumentsANC842ANC8422026-05-12
03700569605094Newclip InstrumentsANC838ANC8382026-05-12
03700569605100Newclip InstrumentsANC839ANC8392026-05-12
03700569610555Newclip InstrumentsANC808ANC8082026-05-12
03700569610579Newclip InstrumentsANC845ANC8452026-05-12
03700569611361Newclip InstrumentsANC740ANC7402026-05-12
03700569611378Newclip InstrumentsANC739ANC7392026-05-12
03700569611385Newclip InstrumentsANC738ANC7382026-05-12
03700569611392Newclip InstrumentsANC737ANC7372026-05-12
03700569612740Newclip InstrumentsANC741ANC7412026-05-12
03700569619435Newclip InstrumentsANC657ANC6572026-05-12
03700569621759Newclip InstrumentsANC652ANC6522026-05-12
03700569621766Newclip InstrumentsANC652ANC6522026-05-12
03700569622633Newclip InstrumentsANC614/BANC614/B2026-05-12
03700569622640Newclip InstrumentsANC614/CANC614/C2026-05-12
03700569622664Newclip InstrumentsANC620ANC6202026-05-12
03700569622671Newclip InstrumentsANC621ANC6212026-05-12
03700569622688Newclip InstrumentsANC622ANC6222026-05-12

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