PROGENIX™ PUTTY and PROGENIX™ PLUS
GUDID 00763000140519
DBM 005001 PROGENIX PUTTY 1CC
MEDTRONIC SOFAMOR DANEK, INC.
Bone matrix implant, human-derived| Primary Device ID | 00763000140519 |
| NIH Device Record Key | f69263c7-3c1d-43fe-83f4-ed87e32e1170 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROGENIX™ PUTTY and PROGENIX™ PLUS |
| Version Model Number | 005001 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| 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 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
| Special Storage Condition, Specify | Between 0 and 0 *store at ambient temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000140519 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060794
FDA Product Code
| MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
On-Brand Devices [PROGENIX™ PUTTY and PROGENIX™ PLUS]
| 00763000140571 | DBM 006010 PROGENIX PLUS PUTTY 10CC |
| 00763000140564 | DBM 006005 PROGENIX PLUS PUTTY 5CC |
| 00763000140557 | DBM 006002 PROGENIX PLUS PUTTY 2.5CC |
| 00763000140540 | DBM 006001 PROGENIX PLUS PUTTY 1CC |
| 00763000140533 | DBM 005110 PROGENIX PUTTY 10CC |
| 00763000140526 | DBM 005005 PROGENIX PUTTY 5CC |
| 00763000140519 | DBM 005001 PROGENIX PUTTY 1CC |
| 00763000140502 | DBM 000505 PROGENIX PUTTY .5CC |
Trademark Results [PROGENIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGENIX 98463197 not registered Live/Pending |
Hunt, Christian 2024-03-22 |
 PROGENIX 87007945 not registered Dead/Abandoned |
Concept Laboratories, Inc. 2016-04-20 |
 PROGENIX 78199350 not registered Dead/Abandoned |
Medtronic, Inc. 2003-01-02 |
 PROGENIX 77081784 3373649 Live/Registered |
Warsaw Orthopedic, Inc. 2007-01-12 |
 PROGENIX 75142407 not registered Dead/Abandoned |
OSIRIS THERAPEUTICS, INC. 1996-07-30 |
 PROGENIX 74583361 not registered Dead/Abandoned |
PROGENIX CORPORATION 1994-10-07 |
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