Phasix™ ST Mesh with Echo 2™ Positioning System 1213035
GUDID 00801741161308
Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse
Davol Inc.
Abdominal hernia surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00801741161308 |
| NIH Device Record Key | 51b81b9e-c067-4266-8855-d7fba1a1782f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Phasix™ ST Mesh with Echo 2™ Positioning System |
| Version Model Number | 1213035 |
| Catalog Number | 1213035 |
| Company DUNS | 001191048 |
| Company Name | Davol 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 | 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(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com |
Device Dimensions
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
| Length | 35 Centimeter |
| Width | 30 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741161308 [Primary] |
FDA Product Code
| OOD | surgical film |
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 | 2019-07-22 |
| Device Publish Date | 2019-07-12 |
On-Brand Devices [Phasix™ ST Mesh with Echo 2™ Positioning System]
| 00801741161308 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
| 00801741161285 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
| 00801741161278 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
| 00801741161261 | Phasix™ ST Mesh with Echo 2™ Positioning System, Oval |
| 00801741161254 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
| 00801741161230 | Phasix™ ST Mesh with Echo 2™ Positioning System, Circle |
| 00801741161223 | Phasix™ ST with Echo 2™ Positioning System, Circle |
| 00801741161216 | Phasix™ ST Mesh with Echo 2™ Positioning System, Circle |
| 00801741161292 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
| 00801741161247 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse |
Trademark Results [Phasix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHASIX 85133298 4576133 Live/Registered |
C. R. Bard, Inc. 2010-09-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.