FDA UDI
In Commercial Distribution
🇺🇸 United States
Carter-thomason CloseSure System XL (REGARD Distributed)
DI: 60888937027053
·
Model: 733776
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Carter-thomason CloseSure System XL (REGARD Distributed)
- Primary DI
- 60888937027053
- Version / Model
- 733776
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- fbdeadab-070b-4e9e-bede-80d6b28390a3
Device Description
Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL. Distributed under REGARD Brand.
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
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60390 | Laparoscopic wound closure thread | A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937027055 | GS1 | Box | 3 | In Commercial Distribution | |
| Primary | 60888937027053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980123 | 000 |