FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile PTFE Surgical Suture
DI: 08056646500116
·
Model: 32.Z3260.00
·
OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Sterile PTFE Surgical Suture
- Primary DI
- 08056646500116
- Version / Model
- 32.Z3260.00
- Company Name
- OMNIA SRL
- Labeler DUNS
- 447696675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 4
- Public Version Date
- 2025-04-22
- Public Version Status
- Update
- Public Device Record Key
- 925e9867-a0c9-4a2f-9a69-c93081464487
Device Description
PTFE Suture 75 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
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 |
|---|---|---|---|---|
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | General, Plastic Surgery | 878.5035 | 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 | 08056646500116 | GS1 | ||||
| Unit of Use | 08056646500109 | GS1 |
Customer Contacts
- Phone
- +390524527453
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT AND KEEP DRY