FDA.report

Ellis External Mini Fixator

Primary DI
04026575229420
Brand
Ellis External Mini Fixator
Company
WALDEMAR LINK GmbH & Co. KG
Model
10-1534/19
Catalog number
10-1534/19
Device description
fixation pins with thread,Thread length 22 mm
Published
2015-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575229420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026575229420040265752294204026575229420

GMDN Terms

TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315675488
Device count
1
DM exempt
true
Premarket exempt
false
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
false

Other Devices From This Company

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04026575346677Endo Model Knee Fusion Nail FK15-8429/2115-8429/212021-01-12
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04026575346714Endo Model Knee Fusion Nail FK15-8430/2215-8430/222021-01-12
04026575346721Endo Model Knee Fusion Nail FK15-8430/2315-8430/232021-01-12
04026575346738Endo Model Knee Fusion Nail FK15-8431/2115-8431/212021-01-12
04026575346745Endo Model Knee Fusion Nail FK15-8431/2215-8431/222021-01-12
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04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02
04026575081059MP Reconstruction System Instruments134-051/002026-02-02
04026575083183Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-01/012026-02-02
04026575083206Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-05/052026-02-02

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