FDA UDI
In Commercial Distribution
🇺🇸 United States
COR-KNOT MESO
DI: 00850012846611
·
Model: 032850
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- COR-KNOT MESO
- Primary DI
- 00850012846611
- Version / Model
- 032850
- Catalog Number
- 032850
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-02-23
- Public Version
- 1
- Public Version Date
- 2026-03-03
- Public Version Status
- New
- Public Device Record Key
- f45049fa-8666-4263-8f9c-66df6efc4dd9
Device Description
COR-KNOT MESO XL Device Twin Pack
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
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
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 | 10850012846618 | GS1 | Carton | 2 | In Commercial Distribution | |
| Primary | 00850012846611 | GS1 | ||||
| Unit of Use | 20850012846615 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]