FDA UDI
In Commercial Distribution
🇺🇸 United States
ImaJin
DI: 05708932059909
·
Model: AJ5083
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ImaJin
- Primary DI
- 05708932059909
- Version / Model
- AJ5083
- Catalog Number
- AJ5083
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-14
- Public Version
- 2
- Public Version Date
- 2023-09-14
- Public Version Status
- Update
- Public Device Record Key
- 6207c184-8e66-4ea9-9475-1c0c91a41f69
Device Description
iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge 8 FR/CH.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| FAD | Stent, ureteral | Gastroenterology, Urology | 876.4620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60755 | Urological surgical procedure kit, non-medicated, single-use | A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932059916 | GS1 | Retail Box | 1 | In Commercial Distribution | |
| Primary | 05708932059909 | GS1 | ||||
| Package | 05708932059923 | GS1 | Shipper Box | 19 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Centimeter | |
| Catheter Gauge | 8 | French |