Primary Device ID | 00822409043217 |
NIH Device Record Key | 22463b84-10e3-48ed-a574-7a584c416cb5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SURESPACE |
Version Model Number | SST2058 |
Company DUNS | 876542390 |
Company Name | Ortho Development Corporation |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 |
Phone | +1(801)553-9991 |
customerservice@odev.com |
Length | 39 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822409043217 [Primary] |
JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-14 |
Device Publish Date | 2019-10-04 |
00822409043231 | TIBIAL SPACER MOLD LARGE |
00822409043224 | TIBIAL SPACER MOLD MEDIUM |
00822409043217 | TIBIAL SPACER MOLD SMALL |
00822409043200 | FEMORAL SPACER MOLD LARGE |
00822409043194 | FEMORAL SPACER MOLD MEDIUM |
00822409043187 | FEMORAL SPACER MOLD SMALL |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SURESPACE 88536225 not registered Live/Pending |
Depuy Synthes, Inc. 2019-07-25 |