FDA UDI
In Commercial Distribution
🇺🇸 United States
Bulkamid
DI: 05704101500500
·
Model: 50050
·
Contura International A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bulkamid
- Primary DI
- 05704101500500
- Version / Model
- 50050
- Company Name
- Contura International A/S
- Labeler DUNS
- 308200307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-10
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 41bd2db8-69d5-4d6d-831b-636c69a8e7df
Device Description
Bulkamid Urethral Bulking System
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
- 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 |
|---|---|---|---|---|
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown | 3 |
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 |
|---|---|---|---|---|---|---|
| Primary | 05704101500500 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from direct sunlight