FDA.report

GUARDIAN®

Primary DI
25001015
Brand
GUARDIAN®
Company
Microport Orthopedics Inc.
Model
25001015
Catalog number
25001015
Device description
GUARDIAN® STRAIGHT STEM 15mm X 152mm TTnm. w/POROUS COLLAR
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
25001015Direct MarkingHIBCC0
M684250010151PrimaryHIBCC0

GMDN Terms

TermDefinition
Revision coated hip femur prosthesisA sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Length152Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-866-872-0211customerservice2@ortho.microport.com

Regulatory Flags

DUNS number
079118736
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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M684PNV123761ProphecyPNV12376PNV123762026-02-03
M684PNV123771ProphecyPNV12377PNV123772026-02-03
M684PNV123781ProphecyPNV12378PNV123782026-02-03
M684PNV123791ProphecyPNV12379PNV123792026-02-03
M684PNV123801ProphecyPNV12380PNV123802026-02-03
M684PNV123811ProphecyPNV12381PNV123812026-02-03
M684PNV123821ProphecyPNV12382PNV123822026-02-03
M684PNV123831ProphecyPNV12383PNV123832026-02-03
M684PNV123841ProphecyPNV12384PNV123842026-02-03
M684PNV123851ProphecyPNV12385PNV123852026-02-03
M684PNV123861ProphecyPNV12386PNV123862026-02-03
M684PNV123871ProphecyPNV12387PNV123872026-02-03
M684PNV123881ProphecyPNV12388PNV123882026-02-03
M684PNV123891ProphecyPNV12389PNV123892026-02-03
M684PNV123901ProphecyPNV12390PNV123902026-02-03
M684PNV123911ProphecyPNV12391PNV123912026-02-03
M684PNV123921ProphecyPNV12392PNV123922026-02-03
M684PNV123931ProphecyPNV12393PNV123932026-02-03

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