FDA UDI
In Commercial Distribution
🇺🇸 United States
gSource
DI: 00840314249074
·
Model: CD.50.5980
·
GSOURCE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- gSource
- Primary DI
- 00840314249074
- Version / Model
- CD.50.5980
- Catalog Number
- CD.50.5980
- Company Name
- GSOURCE LLC
- Labeler DUNS
- 008162518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-06
- Public Version
- 1
- Public Version Date
- 2022-10-14
- Public Version Status
- New
- Public Device Record Key
- af61c356-b50d-445f-8ae9-19d21f708429
Device Description
g2 Fox Curette 5 3/4" 4.0mm round
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62558 | General-purpose curette | A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314249074 | GS1 |