FDA UDI
In Commercial Distribution
🇺🇸 United States
Phasix™ ST Mesh with Open Positioning System,
DI: 00801741163197
·
Model: 1220812
·
Davol Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phasix™ ST Mesh with Open Positioning System,
- Primary DI
- 00801741163197
- Version / Model
- 1220812
- Catalog Number
- 1220812
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-19
- Public Version
- 1
- Public Version Date
- 2019-06-27
- Public Version Status
- New
- Public Device Record Key
- c5685fa4-b5fc-43e3-bfe4-3b3add13227b
Device Description
Phasix™ ST Mesh with Open Positioning System, Oval
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOD | surgical film | General, Plastic Surgery | 878.3300 | 2 |
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
| OWT | Mesh, surgical, absorbable, abdominal hernia | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63946 | Abdominal hernia surgical mesh, synthetic polymer, bioabsorbable | A sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of bioabsorbable synthetic polymer(s) intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer, positioner, trocar) may be included. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741163197 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8 | Centimeter | |
| Length | 12 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius