FDA UDI
In Commercial Distribution
🇺🇸 United States
Optilene
DI: 04046964239472
·
Model: C3095710
·
B BRAUN SURGICAL SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
Basic Information
- Brand Name
- Optilene
- Primary DI
- 04046964239472
- Version / Model
- C3095710
- Catalog Number
- C3095710
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2015-08-18
- Public Version
- 11
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- a664910e-b696-458e-9431-40516b8c5b3c
Device Description
OPTILENE 2/0 (3) 120CM 2XHR26 CV RCP
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 |
|---|---|---|---|---|
| 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 | 04046964239472 | GS1 | ||||
| Unit of Use | 04046964239465 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size of Thread (USP - Others) : 2/0 | ||
| Length | 120.00 | Centimeter | |
| Device Size Text, specify | Thread Material : polypropylene with polyethylen |