FDA UDI
In Commercial Distribution
🇺🇸 United States
Suture USP 2-0
DI: 17350154050513
·
Model: BOM 1020S rev 05 Needle & Suture Sterilized
·
Suturion AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Suture USP 2-0
- Primary DI
- 17350154050513
- Version / Model
- BOM 1020S rev 05 Needle & Suture Sterilized
- Company Name
- Suturion AB
- Labeler DUNS
- 353236163
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-12-15
- Public Version
- 1
- Public Version Date
- 2025-12-23
- Public Version Status
- New
- Public Device Record Key
- 23588276-9f29-435b-9c63-68203d566d0d
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | 878.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16584 | Polyester suture, bioabsorbable, monofilament, non-antimicrobial | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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 | 17350154050513 | GS1 | ||||
| Unit of Use | 07350154050516 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242835 | 000 |