ZipFix 03501080
GUDID H980035010800
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
SYNTHES (U.S.A.) LP
Orthopaedic cerclage applier| Primary Device ID | H980035010800 |
| NIH Device Record Key | f5f426c2-3bbb-498f-ab84-3a3eec272174 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZipFix |
| Version Model Number | 03.501.080 |
| Catalog Number | 03501080 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819418424 [Direct Marking] |
| GS1 | 10887587010847 [Primary] |
| HIBCC | H980035010800 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110789
FDA Product Code
| JDQ | CERCLAGE, FIXATION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
[H980035010800]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [ZipFix]
| H9800850100120S0 | STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK |
| H9800850100105S0 | STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK |
| H9800850100101S0 | STERNAL ZIPFIX WITH NEEDLE STERILE |
| H980035010800 | APPLICATION INSTRUMENT FOR STERNAL ZIPFIX |
Trademark Results [ZipFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZIPFIX 85060623 4084600 Live/Registered |
DEPUY SYNTHES, INC. 2010-06-11 |
 ZIPFIX 78871744 not registered Dead/Abandoned |
Murphy Philip John 2006-04-28 |
 ZIPFIX 75018225 2102031 Dead/Cancelled |
ProCD, Inc. 1995-11-13 |
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