Primary Device ID | M9701000042450 |
NIH Device Record Key | 8fcbad5c-7189-48a1-875e-df4ccf517696 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Morphix XT |
Version Model Number | 1000-04-245 |
Company DUNS | 601306413 |
Company Name | Medshape, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M9701000042450 [Primary] |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | true |
Device Is Sterile | true |
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
[M9701000042450]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2025-07-29 |
Device Publish Date | 2017-05-19 |
M9701000042550 | MORPHIX Foot and Ankle, 5.5MM |
M9701000042450 | MORPHIX Foot and Ankle, 4.5MM |
M9701000041250 | MORPHIX Foot and Ankle, 2.5MM |
M9701000032450 | MORPHIX 4.5mm x 9mm Anchor with two USP |
M9701000032350 | MORPHIX 3.5mm x 8mm Anchor with two USP |
M9701000032250 | MORPHIX 2.5mm x 7mm Anchor with two USP |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MORPHIX XT 90080830 not registered Live/Pending |
MedShape, Inc. 2020-07-29 |