Dynex

Primary DI
00841731124197
Brand
Dynex
Company
VILEX LLC
Model
DF-R100-230
Device description
Full Ring 230mm
Published
2021-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731124197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731124197008417311241978417311241970841731124197

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones 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, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117502293
Device count
1
DM exempt
false
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731135490TITANEXART-HD65-40ART-HD65-402026-03-03
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731149077DYNEX MICROMR-900-PE-04MR-900-PE-042026-03-03
00841731137548TITANEX TH20-16T-092026-02-09
00841731137555TITANEX TH20-18T-092026-02-09
00841731137562TITANEX TH20-20T-092026-02-09
00841731137579TITANEX TH20-22T-092026-02-09
00841731137586TITANEX TH20-24T-092026-02-09
00841731137593TITANEX TH20-26T-092026-02-09
00841731137609TITANEX TH20-28T-092026-02-09
00841731137616TITANEX TH20-30T-092026-02-09
00841731137623TITANEX TH20-32T-092026-02-09
00841731137630TITANEX TH20-34T-092026-02-09
00841731137647TITANEX TH20-36T-092026-02-09
00841731137654TITANEX TH20-38T-092026-02-09
00841731137661TITANEX TH20-40T-092026-02-09
00841731137678TITANEX TH20-42T-092026-02-09
00841731137685TITANEX TH20-44T-092026-02-09
00841731137692TITANEX TH20-46T-092026-02-09
00841731137708TITANEX TH20-48T-092026-02-09

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