FDA UDI
In Commercial Distribution
🇺🇸 United States
DUOLOCK
DI: 00768455108671
·
Model: 175652
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- DUOLOCK
- Primary DI
- 00768455108671
- Version / Model
- 175652
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 3
- Public Version Date
- 2023-05-19
- Public Version Status
- Update
- Public Device Record Key
- c4c75fc7-a346-4d7e-b2a8-6abc15a83e84
Device Description
Duolock® Curved Tail Closures
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZS | APPLIANCE, COLOSTOMY, DISPOSABLE | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37502 | Ostomy bag closure device | A device intended to facilitate the emptying and/or reclosure of an open-ended ostomy bag. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455108678 | GS1 | 48 | In Commercial Distribution | ||
| Primary | 00768455108671 | GS1 | ||||
| Unit of Use | 00768455172948 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]