Primary Device ID | 10381780364856 |
NIH Device Record Key | cb536764-105a-49dd-a773-99df15e629ca |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® |
Version Model Number | CSA093004 |
Catalog Number | CSA-0930-04 |
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 | |
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 | |
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 Issuing Agency | Device ID |
---|---|
GS1 | 10381780364856 [Primary] |
OJH | Orthopedic tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
[10381780364856]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-23 |
Device Publish Date | 2019-12-13 |
M269PUL0920087011 | Integra®Surgical Instruments The pin puller is used to slide over objects that have been drille |
M269EXT200001 | Integra®Surgical Instruments The Trial Extractor is used to remove trial implants. |
M269EXT100011 | Integra®Surgical Instruments MCP, Extractor, Implant The Implant Extractor is used to remove im |
10381780364870 | Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-LP Plate |
10381780364863 | Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-GT Plate |
10381780364856 | Proximal Humeral Fracture Plate System Screw Caddy Lid |
10381780364849 | Proximal Humeral Fracture Plate System Screw Caddy Base |
10381780364832 | Proximal Humeral Fracture Plate System Tray Upper |
10381780364825 | Proximal Humeral Fracture Plate System Tray Base |
10381780364221 | Surgical Instruments - 2.0mm K-wire - Threaded |
10381780364214 | Surgical Instruments - 2.0mm K-wire - Smooth |
10381780364061 | Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-GT Plate |
10381780364054 | Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-LP Plate |
10381780250548 | Humeral Resurfacing Arthroplasty Humeral Broach Sz. 3 |
10381780250531 | Humeral Resurfacing Arthroplasty Humeral Broach Sz. 2 |
10381780250524 | Humeral Resurfacing Arthroplasty Humeral Broach Sz. 1 |
M2695030042501 | Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t |
M26922042501 | Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t |
M269122250200021 | Integra® External Fixation System The punch is used for the half pin drill guide in the externa |
M269SDGTFS351 | Integra®Total Foot System The snap-on drill guide is used for precision and accuracy when drill |
M269SDGTFS271 | Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril |
M269SDGTFS251 | Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril |
M269SDGTFS181 | Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril |
M269RIGTFS181 | Integra® Total Foot System The interfrag drill guide right is used for precision and accuracy w |
M269LIGTFS181 | Integra®Total Foot System The interfrag drill guide is used for precision and accuracy when dri |
M269LDGTFS251 | Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill |
M269LDGTFS181 | Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill |
M269CDGTFS181 | Integra® Total Foot System The compression drill guide is used for precision and accuracy when |
M2695030035451 | Integra® Total Foot System The drill guide is used for precision and accuracy when drilling. |
M269SCR09200600011 | Integra®Surgical Instruments The 1/8 Hex Driver is used to tighten or loosen screws. |
M269PIN09200510011 | Integra®Surgical Instruments The fixation pin helps with stabilization. |
M269G107992B1 | Integra®Surgical Instruments The driver handle is provided with a small AO adaptor. |
M269G107991B1 | Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone. |
M269MRHRMR031 | Integra® Modular Radial Head MRH Reamer Sz. 03 The Modular Radial Head Reamer compresses and/ |
M269MRHRMR021 | Integra® Modular Radial Head MRH Reamer Sz. 02 The Modular Radial Head Reamer compresses and/ |
M269MRHRMR011 | Integra® Modular Radial Head MRH Reamer Sz. 01 The Modular Radial Head Reamer compresses and/ |
M269MRHPLN001 | Integra® Modular Radial Head The planar is used with the modular radial head. |
M269CCR89502241 | Integra® Total Foot System Cone Spherical Reamer Sz. 24mm The Cone cannulated reamer is intende |
M269CCR89502211 | Integra® Total Foot System Cone Spherical Reamer Sz. 21mm The Cone cannulated reamer is intende |
M269CCR89502191 | Integra® Total Foot System Cone Spherical Reamer Sz. 19mm The Cone cannulated reamer is intende |
M269CCR89502161 | Integra® Total Foot System Cone Spherical Reamer Sz. 16mm The Cone cannulated reamer is intende |
M269CCR89501241 | Integra® Total Foot System Cup Spherical Reamer Sz. 24mm The Cup cannulated reamer is intended |
M269CCR89501211 | Integra® Total Foot System Cup Spherical Reamer Sz. 21mm The Cup cannulated reamer is intended |
M269CCR89501191 | Integra® Total Foot System Cup Spherical Reamer Sz. 19mm The Cup cannulated reamer is intended |
10381780245230 | Surgical Instruments Driver Handle w/SM AO |
10381780533733 | Surgical Instruments Torque Limiter |
M269G108404B1 | Integra®Surgical Instruments The T-handle is provided with a large AO adaptor. |
M269OSG442001 | Silicone PIP Cut Guide |
M269OSG20040PV1 | PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 40 |
M269OSG20040P1 | PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40 |