FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED INCORPORATED
DI: 00198506074615
·
Model: 52255-79B16-SS
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELMED INCORPORATED
- Primary DI
- 00198506074615
- Version / Model
- 52255-79B16-SS
- Catalog Number
- 52255-79B16-SS
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-22
- Public Version
- 1
- Public Version Date
- 2025-01-30
- Public Version Status
- New
- Public Device Record Key
- 3053b3df-73e4-4c75-9a88-5f26c3a3ea53
Device Description
5MM, 33CM, BIOPSY SPOON FORCEPS W/ TOOTH, (SEMM-TYPE), STAINLESS STEEL SHAFT, ROTATABLE, ONE PIECE W/ FLUSHPORT, TYPE 16 HANDLE: NON-INSULATED STAINLESS STEEL W/ SPRING ASSIST CLOSING
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35732 | Rigid endoscopic biopsy forceps, reusable | A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198506074615 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]