FDA UDI
In Commercial Distribution
🇺🇸 United States
SOFIA VITALITEC
DI: 03661522040102
·
Model: VSJ-1807
·
PETERS SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SOFIA VITALITEC
- Primary DI
- 03661522040102
- Version / Model
- VSJ-1807
- Catalog Number
- VSJ-1807
- Company Name
- PETERS SURGICAL
- Labeler DUNS
- 265741780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 4
- Public Version Date
- 2023-07-12
- Public Version Status
- Update
- Public Device Record Key
- 089971e0-edf7-4875-86d7-0e4c0698032d
Device Description
Atraumatic Spring Clip, 1/4 FORCE
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62480 | Surgical bulldog clamp, single-use | A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 01366152204109 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 03661522040102 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Jaw opening = 7 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the unopened sterile pack in a cool, dry, well-ventilated place away from extremes of temperature or humidity.