FDA UDI
In Commercial Distribution
🇺🇸 United States
Golnit PTFE Suture
DI: 00860293000664
·
Model: mRD601338-45
·
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
- 00860293000664
- Version / Model
- mRD601338-45
- Company Name
- Golnit Sutures
- Labeler DUNS
- 079932697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2018-03-08
- Public Version
- 2
- Public Version Date
- 2018-10-10
- Public Version Status
- Update
- Public Device Record Key
- 080b73d3-e310-4829-8a2b-9800411f3f7c
Device Description
PTFE Non-absorbable Suture 18 inch in length, USP 6/0, Reverse Cutting Needle, 13mm, 3/8 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 |
|---|---|---|---|---|
| 17467 | Polytetrafluoroethylene suture | A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860293000664 | GS1 | ||||
| Unit of Use | 00860000584029 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 13mm 3/8 Circle Reverse Cutting Needle | ||
| Device Size Text, specify | USP 6/0 Suture Thread | ||
| Length | 18 | Inch |