Primary Device ID | M2483480951 |
NIH Device Record Key | 5158c857-2d70-411d-a45d-bee7b49128a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® Freedom Wrist Arthroplasty System |
Version Model Number | 348095 |
Catalog Number | 348095 |
Company DUNS | 942377524 |
Company Name | Ascension Orthopedics, Inc. |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780278375 [Primary] |
HIBCC | M2483480951 [Secondary] |
HXX | SCREWDRIVER |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
[M2483480951]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2018-03-09 |
M2483481951 | Integra® Freedom Wrist Arthroplasty System Anti-Rotation Pin |
M2483481861 | Integra® Freedom Wrist Arthroplasty System Radial Trial Remover |
M2483481841 | Integra® Freedom Wrist Arthroplasty System Radial Impactor |
M2483481811 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 4, Right |
M2483481781 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 4, Left |
M2483481751 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 3, Right |
M2483481721 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 3, Left |
M2483481691 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 2, Right |
M2483481661 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 2, Left |
M2483481631 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 1, Right |
M2483481601 | Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 1, Left |
M2483481561 | Integra® Freedom Wrist Arthroplasty System Box Punch, Right |
M2483481541 | Integra® Freedom Wrist Arthroplasty System Box Punch, Left |
M2483481461 | Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 3 |
M2483481421 | Integra® Freedom Wrist Arthroplasty System Radial IM Guide Rod |
M2483481411 | Integra® Freedom Wrist Arthroplasty System Radial IM Guide Rod |
M2483481401 | Integra® Freedom Wrist Arthroplasty System Radial Template, Size 2 |
M2483481391 | Integra® Freedom Wrist Arthroplasty System Radial Template, Size 1 |
M2483481381 | Integra® Freedom Wrist Arthroplasty System Radial Score Guide |
M2483481061 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 3 Left |
M2483481051 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 2 Right |
M2483481041 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 2 Left |
M2483481031 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 1 Right |
M2483481021 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 1 Left |
M2483481011 | Integra® Freedom Wrist Arthroplasty System 2.5mm Hex Driver |
M2483480951 | Integra® Freedom Wrist Arthroplasty System T15 Star Driver |
M2483480941 | Integra® Freedom Wrist Arthroplasty System 4.0mm Stop Drill Bit |
M2483480931 | Integra® Freedom Wrist Arthroplasty System 3.5mm Cannulated Drill Bit |
M2483480921 | Integra® Freedom Wrist Arthroplasty System 2.5mm Cannulated Drill Bit |
M2483480911 | Integra® Freedom Wrist Arthroplasty System K-Wire Depth Gauge |
M2483480901 | Integra® Freedom Wrist Arthroplasty System 0.54" (1.4 mm) K-Wire |
M2483480891 | Integra® Freedom Wrist Arthroplasty System Tissue Protective Sleeve |
M2483480881 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Impactor |
M2483480831 | Integra® Freedom Wrist Arthroplasty System Carpal Plate Impactor |
M2483480811 | Integra® Freedom Wrist Arthroplasty System Carpal Cement Reamer |
M2483480631 | Integra® Freedom Wrist Arthroplasty System Hamate Feeler |
M2483480601 | Integra® Freedom Wrist Arthroplasty System Carpal Guide Bar |
M2483480591 | Integra® Freedom Wrist Arthroplasty System K-Wire Sleeve |
M2483480541 | Integra® Freedom Wrist Arthroplasty System Carpal Sizer |
M2483480521 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, +4 mm |
M2483480511 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, +2 mm |
M2483480501 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, Standard |
M2483480491 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, +4 mm |
M2483480481 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, +2 mm |
M2483480471 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, Standard |
M2483480461 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, +4 mm |
M2483480451 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, +2 mm |
M2483480441 | Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, Standard |
M2483480431 | Integra® Freedom Wrist Arthroplasty System Carpal Plate Trial, Size 3 |
M2483480421 | Integra® Freedom Wrist Arthroplasty System Carpal Plate Trial, Size 2 |