FDA UDI
In Commercial Distribution
🇺🇸 United States
FILBLOC PERMANENT
DI: 38033439007138
·
Model: PZ890
·
ASSUT EUROPE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FILBLOC PERMANENT
- Primary DI
- 38033439007138
- Version / Model
- PZ890
- Company Name
- ASSUT EUROPE SPA
- Labeler DUNS
- 654747567
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 2
- Public Version Date
- 2026-02-26
- Public Version Status
- Update
- Public Device Record Key
- 23748860-7330-43bc-9229-e6b4e7565ba0
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 |
|---|---|---|---|---|
| 64255 | Barbed polyolefin/fluoropolymer suture | A single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) or fluoropolymer (e.g., polyvinylidene fluoride) intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) to eliminate the need to tie a knot, and may include disposable suture application devices. It provides temporary wound support until the wound heals to withstand normal stress, after which it may be removed. It does not include antimicrobial 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 | 38033439007138 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171039 | 000 |