FDA.reportPublic FDA data

NEXIS

Primary DI
03700879512808
Brand
NEXIS
Company
NOVASTEP
Model
CKW05002
Catalog number
CKW05002
Device description
Threaded K-Wire Ø2,5 lg 200
Published
2020-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700879512808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700879512808037008795128083700879512808

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

Contacts

PhoneEmail
+33299338650contact@novastep-ortho.com

Regulatory Flags

DUNS number
264255288
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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03700879515182PECA®2.0PS060124PS0601242025-11-07
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03700879515205PECA®2.0PS060128PS0601282025-11-07
03700879515212PECA®2.0PS060130PS0601302025-11-07
03700879515229PECA®2.0PS060132PS0601322025-11-07
03700879515236PECA®2.0PS060134PS0601342025-11-07
03700879515243PECA®2.0PS060136PS0601362025-11-07
03700879515250PECA®2.0PS060138PS0601382025-11-07
03700879515267PECA®2.0PS060140PS0601402025-11-07
03700879515274PECA®2.0PS060142PS0601422025-11-07
03700879515281PECA®2.0PS060144PS0601442025-11-07
03700879515298PECA®2.0PS060146PS0601462025-11-07
03700879515304PECA®2.0PS060148PS0601482025-11-07

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