FDA UDI
In Commercial Distribution
🇺🇸 United States
FILBLOC PERMANENT
DI: 18033439169238
·
Model: PS028HHAC
·
ASSUT EUROPE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FILBLOC PERMANENT
- Primary DI
- 18033439169238
- Version / Model
- PS028HHAC
- Company Name
- ASSUT EUROPE SPA
- Labeler DUNS
- 654747567
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-16
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- abbde8e6-4017-474a-869f-5fa7cf80a852
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | 878.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13909 | Polyolefin/fluoropolymer suture, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18033439169238 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171039 | 000 |