FDA.report

APTUS

Primary DI
07630894810985
Brand
APTUS
Company
Medartis AG
Model
A-5046.65/2S
Catalog number
A-5046.65/2S
Device description
2.0 K-Wire, 80mm, Olive 30mm, No Thread
Published
2023-11-15
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

Related Records

Product Codes

CodeName
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630894810985PrimaryGS10
07630894821059Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630894810985076308948109857630894810985
07630894821059076308948210597630894821059

GMDN Terms

TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
480054895
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
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
07630894829079APTUSA-2065A-20652026-01-09
07630894829062APTUSA-2056A-20562025-12-15
07630037863670APTUSA-4750.70/1SA-4750.70/1S2025-07-31
07630037865889APTUSA-3837SA-3837S2025-07-31
07630037883791APTUSA-5800.65/1SA-5800.65/1S2025-07-31
07630037883821APTUSA-5800.70/1SA-5800.70/1S2025-07-31
07630037883852APTUSA-5800.75/1SA-5800.75/1S2025-07-31
07630037883975APTUSA-5830.40/1SA-5830.40/1S2025-07-31
07630037883999APTUSA-5830.45/1SA-5830.45/1S2025-07-31
07630037884019APTUSA-5830.50/1SA-5830.50/1S2025-07-31
07630037884033APTUSA-5830.55/1SA-5830.55/1S2025-07-31
07630037884057APTUSA-5830.60/1SA-5830.60/1S2025-07-31
07630037884071APTUSA-5830.65/1SA-5830.65/1S2025-07-31
07630037884095APTUSA-5830.70/1SA-5830.70/1S2025-07-31
07630037884101APTUSA-5830.75/1SA-5830.75/1S2025-07-31
07630037884767APTUSA-5850.65/1SA-5850.65/1S2025-07-31
07630037884798APTUSA-5850.70/1SA-5850.70/1S2025-07-31
07630037884828APTUSA-5850.75/1SA-5850.75/1S2025-07-31
07630037897125APTUSA-4350.14TPA-4350.14TP2025-07-31
07630894811784APTUSA-4340.32TPA-4340.32TP2025-07-31

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