FDA.report

NA

Primary DI
00889797102834
Brand
NA
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
RR5025TN
Catalog number
RR5025TN
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDWPIN, FIXATION, THREADED

Product Code Classifications

CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797102834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797102834008897971028348897971028340889797102834

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length180Millimeter
Outer Diameter5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
true
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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