Primary Device ID | M269FS40201 |
NIH Device Record Key | ee06b7d2-fd85-4dbc-b31e-632b3dd3c534 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra®Ti6® |
Version Model Number | FS4020 |
Catalog Number | FS4020 |
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 | false |
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 | |
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 Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780245193 [Primary] |
HIBCC | M269FS40201 [Secondary] |
HTJ | GAUGE, DEPTH |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
[M269FS40201]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-12-15 |
Device Publish Date | 2017-09-05 |
M269KW11051 | Integra® Ti6® The Ti6 TH-Series K-Wire is used for temporary fixation. |
M269KW11041 | Integra® Ti6® The Ti6 TC-Series Threaded K-Wire is used for temporary fixation. |
M269KW11031 | Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation. |
M269KW11021 | Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation. |
M269FS50101 | Integra® Ti6® The 3-prong driver shaft is used to create holes in conjunction with the Ti6 TQ- |
M269FS40301 | Integra® Ti6® The cannulated relief drill is used with the TH-series screws. |
M269FS40201 | Integra® Ti6® The TH-Series cannulated depth gauge is a tool used to measure the depth of a dr |
M269FS40101 | Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6 |
M269FS30501 | Integra® Ti6® The cannulated overdrill is used with the TC-series 3.0/4.0 mm screws. |
M269FS30421 | Integra® Ti6® The cannulated drill is used with the TC-series 2.0/2.5 mm screws. |
M269FS30401 | Integra® Ti6® The combination cannulated Countersink and Depth Gauge allows for precise measur |
M269FS30301 | Integra® Ti6® The combination cannulated Countersink and Depth Gauge allows for precise measur |
M269FS30201 | Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6 |
M269FS30101 | Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6 |
M269FS10061 | Integra® The handle is used to assist in orthopedic surgery. |
10381780115601 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115595 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115588 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115571 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115564 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115557 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115540 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115533 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115526 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115519 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115502 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115496 | Ti6 QuickSnap - TQ-Series Screws (Titanium QuickSnap) is a snap-off, solid core screw used in |
10381780115489 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115472 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115465 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115458 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115441 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115434 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115427 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115410 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115403 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115397 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115380 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115373 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115366 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115359 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115342 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115335 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115328 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115311 | Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bon |
10381780115304 | Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone scre |
10381780115298 | Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone scre |
10381780115281 | Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone scre |
10381780115274 | Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone scre |
10381780115267 | Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone scre |