FDA UDI
In Commercial Distribution
🇺🇸 United States
gSource
DI: 00840314209979
·
Model: gS 27.7546
·
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
- 00840314209979
- Version / Model
- gS 27.7546
- Catalog Number
- gS 27.7546
- Company Name
- GSOURCE LLC
- Labeler DUNS
- 008162518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-02
- Public Version
- 3
- Public Version Date
- 2022-09-05
- Public Version Status
- Update
- Public Device Record Key
- 8f897e62-116b-474c-8b38-61f77540a352
Device Description
Dix Spud & Needle DE invertable 4 3/4"
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 |
|---|---|---|---|---|
| 46549 | Eye spud/needle | A hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314209979 | GS1 |