FDA UDI
In Commercial Distribution
🇺🇸 United States
g-Cath Suture Anchor Delivery Catheter
DI: 00860009064713
·
Model: g-Cath EZ
·
Usgi Medical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- g-Cath Suture Anchor Delivery Catheter
- Primary DI
- 00860009064713
- Version / Model
- g-Cath EZ
- Catalog Number
- 208100
- Company Name
- Usgi Medical, Inc.
- Labeler DUNS
- 112331090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 1
- Public Version Date
- 2022-12-28
- Public Version Status
- New
- Public Device Record Key
- c18e86da-f58c-4af8-aed2-b5de7e689712
Device Description
g-Cath Suture Anchor Delivery Catheter
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
- 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 |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
| GDW | Staple, Implantable | General, Plastic Surgery | 878.4750 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13906 | Polyester suture, non-bioabsorbable, multifilament | A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860009064710 | GS1 | Carton | 6 | In Commercial Distribution | |
| Primary | 00860009064713 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102916 | 000 |