Primary Device ID | M7161121525220 |
NIH Device Record Key | ed5a7115-068a-4d0e-8d2a-59fd84789968 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OrthoMedFlex |
Version Model Number | 112152522 |
Catalog Number | 112-152-522 |
Company DUNS | 034442726 |
Company Name | ORTHOMEDFLEX LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M7161121525220 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
[M7161121525220]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-10 |
Device Publish Date | 2019-04-02 |
M7161121525260 | Trial Liner 20° 36/60-70 (E) |
M7161121525250 | Trial Liner 20° 36/56-58 (D) |
M7161121525240 | Trial Liner 20° 36/52-54 (C) |
M7161121525230 | Trial Liner 20° 32/60-70 (E) |
M7161121525220 | Trial Liner 20° 32/56-58 (D) |
M7161121525210 | Trial Liner 20° 32/52-54 (C) |
M7161121525200 | Trial Liner 20° 32/48-50 (B) |
M7161121525190 | Trial Liner 20° 28/52-54 (C) |
M7161121525180 | Trial Liner 20° 28/48-50 (B) |
M7161121525170 | Trial Liner 20° 28/44-46 (A) |
M7161121525160 | Trial Liner 20° 22/40-42 |
M7161121588520 | Trial Liner, 28/52-54C (+4 10° Hooded Lateralised) |
M7161121588500 | Trial Liner, 28/48-50B (+4 10° Hooded Lateralised) |
M7161121588440 | Trial Liner, 28/44-46A (+4 10° Hooded Lateralised) |
M7161121586600 | Trial Liner, 36/60-68E (+4 10° Hooded Lateralised) |
M7161121586560 | Trial Liner, 36/56-58D (+4 10° Hooded Lateralised) |
M7161121586520 | Trial Liner, 36/52-54C (+4 10° Hooded Lateralised) |
M7161121582600 | Trial Liner, 32/60-68E (+4 10° Hooded Lateralised) |
M7161121582560 | Trial Liner, 32/56-58D (+4 10° Hooded Lateralised) |
M7161121582520 | Trial Liner, 32/52-54C (+4 10° Hooded Lateralised) |
M7161121582500 | Trial Liner, 32/48-50B (+4 10° Hooded Lateralised) |
M7161121582400 | Trial Liner, 22/40-42 (+4 10° Hooded Lateralised) |
M7161121578520 | Trial Liner, 28/52-54C (+4 Neutral Lateralised) |
M7161121578500 | Trial Liner, 28/48-50B (+4 Neutral Lateralised) |
M7161121578440 | Trial Liner, 28/44-46A (+4 Neutral Lateralised) |
M7161121576600 | Trial Liner, 36/60-68E (+4 Neutral Lateralised) |
M7161121576560 | Trial Liner, 36/56-58D (+4 Neutral Lateralised) |
M7161121576520 | Trial Liner, 36/52-54C (+4 Neutral Lateralised) |
M7161121572600 | Trial Liner, 32/60-68E (+4 Neutral Lateralised) |
M7161121572560 | Trial Liner, 32/56-58D (+4 Neutral Lateralised) |
M7161121572520 | Trial Liner, 32/52-54C (+4 Neutral Lateralised) |
M7161121572500 | Trial Liner, 32/48-50B (+4 Neutral Lateralised) |
M7161121572400 | Trial Liner, 22/40-42 (+4 Neutral Lateralised) |
M7161122500790 | Femoral Head Extractor Long |
M7161122500380 | Femoral Head Extractor |
M7161122401010 | Bipolar Head Inserter |
M716101144010 | Thread Adaptor |
M7161011410 | Femoral Head Extractor |
M716AL2361560 | Tryon Acetabular Cup Liner, Neutral, SIZE 36/56-58mm XL - UHMWPE |
M716AFS65200 | Tryon Acetabular Bone Screw, SIZE 20mm Ti6AI4V Alloys |
M7161111243680 | 68mm Acetabular Cup (3-Hole) HA |
M7161111243660 | 66mm Acetabular Cup (3-Hole) HA |
M7161111243640 | 64mm Acetabular Cup (3-Hole) HA |
M7161111243620 | 62mm Acetabular Cup (3-Hole) HA |
M7161111243600 | 60mm Acetabular Cup (3-Hole) HA |
M7161111243580 | 58mm Acetabular Cup (3-Hole) HA |
M7161111243560 | 56mm Acetabular Cup (3-Hole) HA |
M7161111243540 | 54mm Acetabular Cup (3-Hole) HA |
M7161111243520 | 52mm Acetabular Cup (3-Hole) HA |
M7161111243500 | 50mm Acetabular Cup (3-Hole) HA |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOMEDFLEX 86216632 4886418 Live/Registered |
Orthomedflex, LLC 2014-03-10 |