FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00842180132016
·
Model: 52224-77A
·
ELMED INCORPORATED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELMED
- Primary DI
- 00842180132016
- Version / Model
- 52224-77A
- Catalog Number
- 52224-77A
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-19
- Public Version
- 2
- Public Version Date
- 2025-02-19
- Public Version Status
- Update
- Public Device Record Key
- 68062dc7-923b-481a-8193-1f0dba14c979
Device Description
5MM DIA., 24CM, PERITONEAL SCISSORS, TS, EXTRA HARD STEEL, SINGLE-ACTION, INSULATED SHAFT & HANDLE W/RF-POST, RIGID-ONE PIECE W/FLUSHPORT
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
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32043 | Laparoscopic surgical procedure kit, non-medicated, reusable | A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842180132016 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]