FDA UDI
In Commercial Distribution
🇺🇸 United States
GP General Purpose Drainage Catheter
DI: H862GPL21030HB0
·
Model: GPL2-1030HB
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GP General Purpose Drainage Catheter
- Primary DI
- H862GPL21030HB0
- Version / Model
- GPL2-1030HB
- Catalog Number
- GPL2-1030HB
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 5
- Public Version Date
- 2022-04-29
- Public Version Status
- Update
- Public Device Record Key
- a50954df-6781-4b9c-92b9-0a950ec9ec86
- Distribution End Date
- 2027-02-28
Device Description
HYDROPHILIC COATED GP LOCKING CATHETER, 10F
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H862GPL21030HB2 | HIBCC | Shipper | 6 | In Commercial Distribution | 2027-02-28 |
| Package | H862GPL21030HB1 | HIBCC | Dispenser | 5 | Not in Commercial Distribution | 2027-02-28 |
| Primary | H862GPL21030HB0 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French | |
| Length | 21 | Centimeter |