| Primary Device ID | M269MRHRMR011 |
| NIH Device Record Key | 519b6e9a-20c7-451c-b9df-5b40abf88cb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® |
| Version Model Number | MRH-RMR-01 |
| Catalog Number | MRHRMR01 |
| 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 | true |
| 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 | |
| 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 Size Text, specify | 0 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780246039 [Primary] |
| HIBCC | M269MRHRMR011 [Secondary] |
| HTO | REAMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
[M269MRHRMR011]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2017-08-30 |
| 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 |