FDA UDI
In Commercial Distribution
🇺🇸 United States
SURJEX
DI: G383HEMOSTATROCHESTERQ4
·
Model: WM3197470, WM3197455
·
SURJEX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SURJEX
- Primary DI
- G383HEMOSTATROCHESTERQ4
- Version / Model
- WM3197470, WM3197455
- Catalog Number
- WM3197470, WM3197455
- Company Name
- SURJEX
- Labeler DUNS
- 645518882
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-31
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- 5a31f52f-37bf-4a87-b393-c6dc4e094185
Device Description
Hemostat Rochester Pean Curved 18cm 7-1/4" Hemostat Rochester Ochsner 1:2 Curved 18cm 7"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62468 | Surgical soft-tissue manipulation forceps, scissors-like, reusable | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G383HEMOSTATROCHESTERQ4 | HIBCC |