FDA UDI
In Commercial Distribution
🇺🇸 United States
Golnit PTFE Suture
DI: 00860293000695
·
Model: mTH501333-45
·
Golnit Sutures
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Golnit PTFE Suture
- Primary DI
- 00860293000695
- Version / Model
- mTH501333-45
- Company Name
- Golnit Sutures
- Labeler DUNS
- 079932697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2018-10-09
- Public Version
- 2
- Public Version Date
- 2023-09-15
- Public Version Status
- Update
- Public Device Record Key
- 705ef60f-bf48-474c-9d38-6c8b169531c3
Device Description
PTFE Non-absorbable Suture 18 inch in length, USP 5/0, Taper Point Needle, 13mm, 1/2 curvature, Sterile
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 | 00860293000695 | GS1 | ||||
| Unit of Use | 00860293000671 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 13mm 1/2 Circle Taper Point Needle | ||
| Length | 18 | Inch | |
| Device Size Text, specify | USP 5/0 Suture Thread |