Biozip 3910-200-020
GUDID 34546540392467
5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER
STRYKER CORPORATION
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 34546540392467 |
| NIH Device Record Key | e6fe42fc-2414-4a01-b6a8-af29ae878f7d |
| Commercial Distribution Discontinuation | 2017-03-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Biozip |
| Version Model Number | 3910-200-020 |
| Catalog Number | 3910-200-020 |
| Company DUNS | 187502109 |
| Company Name | STRYKER CORPORATION |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
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| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx | |
| Phone | +1(866)624-4422 |
| xx@xx.xx |
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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 54 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 54 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540392466 [Primary] |
| GS1 | 34546540392467 [Package] Contains: 04546540392466 Package: pack [5 Units] Discontinued: 2017-03-09 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023192
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-09 |
On-Brand Devices [Biozip]
| 37613154470892 | 6.5MM BIOZIP W/O NEEDLES 2 STRANDS #2 FORCE FIBER |
| 37613154470885 | 6.5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER |
| 37613154019862 | 5MM BIOZIP W/O NEEDLES, 2 STRANDS #2 FORCE FIBER |
| 34546540392467 | 5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER |
| 04546540392435 | 6.5MM BIOZIP DRILL 4.0MM X 13.5MM |
| 04546540392428 | 5.0MM BIOZIP DRILL 3.25MM X 13.5MM |
| 04546540392398 | AWL, 6.5 MM BIOZIP ANCHOR |
| 04546540392381 | AWL, 5.0MM BIOZIP ANCHOR |
Trademark Results [Biozip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOZIP 79038510 3550350 Dead/Cancelled |
S2F FLEXICO 2006-12-05 |
 BIOZIP 77953250 not registered Dead/Abandoned |
The New Bag Company, LLC 2010-03-08 |
 BIOZIP 77920422 3840868 Live/Registered |
STRYKER CORPORATION 2010-01-26 |
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