FDA UDI
In Commercial Distribution
🇺🇸 United States
Soprano
DI: 03600040326756
·
Model: AEHB35
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Soprano
- Primary DI
- 03600040326756
- Version / Model
- AEHB35
- Catalog Number
- AEHB35
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- c68751a9-07e2-4c00-bd6c-cbacf42ec3cc
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| OCY | Endoscopic guidewire, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46691 | Gastro-urological guidewire, single-use | A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03600040326763 | GS1 | Retail Box | 5 | In Commercial Distribution | |
| Primary | 03600040326756 | GS1 | ||||
| Package | 03600040326770 | GS1 | Shipper Box | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.035 | Inch |