FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00842180187382
·
Model: 23-1716
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELMED
- Primary DI
- 00842180187382
- Version / Model
- 23-1716
- Catalog Number
- 23-1716
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-06
- Public Version
- 1
- Public Version Date
- 2024-03-14
- Public Version Status
- New
- Public Device Record Key
- f44c5f76-163b-4896-be94-5dbafa2536fb
Device Description
2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMALL ROUND T-HANDLE AND FEMALE LUER LOCK, CANNULA: 4.2MM DIA. O.D., 3.6MM DIA. I.D.-60CM WORKING LENGTH, PROBE: 3.5MM DIA. AT TIP, 62CM WORKING LENGTH, REUSABLE STAINLESS STEEL, 64CM OVERALL LENGTH - HOFFMAN STYLE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PIY | Stainless Steel Instrument, Shunt System Implantation | Neurology | 882.4545 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11268 | Vascular dilator, reusable | A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842180187382 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]