FDA UDI
In Commercial Distribution
🇺🇸 United States
Cytoplast™ PTFE Suture
DI: D765CS04280
·
Model: CS0428
·
Osteogenics Biomedical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Cytoplast™ PTFE Suture
- Primary DI
- D765CS04280
- Version / Model
- CS0428
- Company Name
- Osteogenics Biomedical Inc
- Labeler DUNS
- 123853058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-28
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- cec666cc-2007-4947-869e-b71ee14a0676
Device Description
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 2-0, 19 mm 3/8 Circle Precision Reverse Cutting Needle
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 |
|---|---|---|---|---|---|---|
| Package | D765CS04281 | HIBCC | 12 | In Commercial Distribution | ||
| Primary | D765CS04280 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 19mm 3/8 Circle RC Needle | ||
| Device Size Text, specify | USP 2-0 Suture Rod | ||
| Length | 28 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius