FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00842180198364
·
Model: ST2422634
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELMED
- Primary DI
- 00842180198364
- Version / Model
- ST2422634
- Catalog Number
- ST2422634
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 1
- Public Version Date
- 2024-05-01
- Public Version Status
- New
- Public Device Record Key
- 02bb659e-62b7-41cc-b918-e9a01c776a8a
Device Description
FOERSTER LUNG GRASPING CLAMP, CURVED LEFT JAWS, 12 MM OVAL RING JAWS WITH RATCHET, 7 MM SHAFT, 9-1/4” (23.5 CM) WORKING LENGTH, 13-1/4” (33.5 CM) OVERALL LENGTH
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 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 | 00842180198364 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181173 | 000 |