FDA UDI
In Commercial Distribution
🇺🇸 United States
Evolution
DI: 10827002480275
·
Model: G48027
·
COOK IRELAND LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Evolution
- Primary DI
- 10827002480275
- Version / Model
- G48027
- Catalog Number
- EVO-22-27-12-D
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f5a2c1eb-88b9-4d0d-95ed-a32bd909c44c
Device Description
EVOLUTION DUODENAL, STENT SYSTEM - UNCOVERED
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 Conditional
- 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 |
|---|---|---|---|---|
| MUM | STENT,METALLIC,EXPANDABLE,DUODENAL | General, Plastic Surgery | 878.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32640 | Bare-metal duodenal stent | A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10827002480275 | 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