FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00198506004056
·
Model: ST3348302RA90
·
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
- 00198506004056
- Version / Model
- ST3348302RA90
- Catalog Number
- ST3348302RA90
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-25
- Public Version
- 1
- Public Version Date
- 2024-05-03
- Public Version Status
- New
- Public Device Record Key
- caac4329-2abf-4cf2-b3d6-2b5344234814
Device Description
BONE CURETTE; SPINAL, 9", #2, REVERSE ANGLE, 90 DEGREE
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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31335 | Bone curette, reusable | A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198506004056 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]