FDA UDI
Not in Commercial Distribution
🇺🇸 United States
COR-KNOT MINI®
DI: 00850200006087
·
Model: 031350
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- COR-KNOT MINI®
- Primary DI
- 00850200006087
- Version / Model
- 031350
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-04
- Public Version
- 4
- Public Version Date
- 2020-07-16
- Public Version Status
- Update
- Public Device Record Key
- 5b396434-96c7-4d8b-a70a-44b3c0ce1880
- Distribution End Date
- 2020-07-15
Device Description
COR-KNOT MINI® COMBO KIT Base Package Type - Kit Each sterile package kit contains (2) single patient use COR-KNOT MINI® Devices and (12) COR-KNOT® QUICK LOADS®.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61353 | Suture clasp, non-bioabsorbable | A small, sterile, implantable fastening device designed to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. It is made of non-bioabsorbable materials [e.g., titanium (Ti)] and is typically implanted with a dedicated applicator. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850200006084 | GS1 | Case | 6 | Not in Commercial Distribution | 2016-08-29 |
| Primary | 00850200006087 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100593 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Centimeter | |
| Outer Diameter | 4 | Millimeter |