FDA UDI
In Commercial Distribution
🇺🇸 United States
PROLENE
DI: 10705031048997
·
Model: PHSM
·
ETHICON INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- PROLENE
- Primary DI
- 10705031048997
- Version / Model
- PHSM
- Catalog Number
- PHSM, PHSM1, PHSM6
- Company Name
- ETHICON INC.
- Labeler DUNS
- 002144145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 8
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 4e51ea5f-e6a2-46fd-9353-f7e1ec0396c1
Device Description
Polypropylene Nonabsorbable Synthetic Surgical Mesh
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 |
|---|---|---|---|---|
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable | An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705031048987 | GS1 | BOX | 3 | In Commercial Distribution | |
| Primary | 10705031048997 | GS1 | ||||
| Package | 20705031049007 | GS1 | BOX | 6 | In Commercial Distribution | |
| Package | 20705031048994 | GS1 | BOX | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]