FDA UDI
In Commercial Distribution
🇺🇸 United States
TroClose1200™
DI: 07290017191027
·
Model: GSTC1200
·
GORDIAN SURGICAL LTD
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TroClose1200™
- Primary DI
- 07290017191027
- Version / Model
- GSTC1200
- Catalog Number
- GSTC1200
- Company Name
- GORDIAN SURGICAL LTD
- Labeler DUNS
- 600087854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-01
- Public Version
- 1
- Public Version Date
- 2026-02-09
- Public Version Status
- New
- Public Device Record Key
- 549dfe26-62d5-4526-a35f-e9022491c680
Device Description
Gordian TroClose1200™ Integrated Port Closure System
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
- 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 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62869 | Laparoscopic access cannulation/wound closure set | A collection of sterile devices which includes a laparoscopic access cannula with a dedicated, implantable, bioabsorbable wound closure thread, intended to: 1) puncture the abdominal wall to create an access port for laparoscopic instruments during laparoscopy; and 2) approximate subcutaneous tissue after removal of the cannula. The access cannula is often provided with a shut-off valve, sealing devices, and may include a trocar blade. The thread is integrated within the cannula and consists of a suture with an attached tag (anchor); the tag is designed to be deployed deep to the wound and the suture ligated upon removal of the cannula. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290017191024 | GS1 | Shelf Box | 6 | In Commercial Distribution | |
| Primary | 07290017191027 | GS1 | ||||
| Package | 27290017191021 | GS1 | Master Box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 8447151080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253620 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 115 | Millimeter | |
| Lumen/Inner Diameter | 12 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius