FDA UDI
In Commercial Distribution
🇺🇸 United States
Silber
DI: 00827002152847
·
Model: G15284
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silber
- Primary DI
- 00827002152847
- Version / Model
- G15284
- Catalog Number
- 020404
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 631566c2-1363-427d-b03d-4333964d9847
Device Description
Silber Aspiration Catheter
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
- 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
- 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 |
|---|---|---|---|---|
| FAP | CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47993 | Epididymal fluid aspiration catheter | A flexible tube designed for the surgical aspiration of epididymal fluid during sperm extraction procedures such as microepididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), and during open testicular procedures. It is typically made of plastic materials [e.g., polyethylene (PE), polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane, or silicone] and is available in various lengths. The aspirate is processed for assisted reproductive technology (ART) procedures such as intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002152847 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.