FDA UDI
In Commercial Distribution
🇺🇸 United States
Leung
DI: 00827002215238
·
Model: G21523
·
COOK IRELAND LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leung
- Primary DI
- 00827002215238
- Version / Model
- G21523
- Catalog Number
- ENBD-6.5-LEUNG-7
- Company Name
- COOK IRELAND LTD
- Labeler DUNS
- 988559035
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2019-10-22
- Public Version Status
- Update
- Public Device Record Key
- 63c0d5be-d7b9-40f1-84df-69ef892dc7fc
Device Description
Leung, Nasal Biliary Drainage Set
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
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47059 | Nasal biliary/pancreatic drainage catheter | A sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002215238 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry location, away from temperature extremes