FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 03600040280478
·
Model: ACXS10
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 03600040280478
- Version / Model
- ACXS10
- Catalog Number
- ACXS10
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 81da37fc-2238-469b-a7e8-33c10adb5128
Device Description
Ureteral Accesss Sheath 35cm
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
- 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 |
|---|---|---|---|---|
| FED | endoscopic access overtube, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47999 | Ureteral dilatation/injection catheter | A sterile, flexible or semi-flexible tube designed to be inserted through the urethra to open or increase the diameter of a constricted or irregular ureteral passage and allow the injection of a contrast medium to access possible submucosal tunnelling. The device is typically made of plastic materials and is available in a variety of diameters and lengths. It may also be used for the injection of a topical anaesthetic; other instruments may be passed through this device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03600040280478 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140523 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French | |
| Catheter Gauge | 12 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place