FDA UDI
In Commercial Distribution
🇺🇸 United States
PEAK MEDICAL
DI: G453335220506BA0
·
Model: 33-52205-06B/A
·
Peak Medical Distribution Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PEAK MEDICAL
- Primary DI
- G453335220506BA0
- Version / Model
- 33-52205-06B/A
- Company Name
- Peak Medical Distribution Inc.
- Labeler DUNS
- 078393632
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-29
- Public Version
- 1
- Public Version Date
- 2023-07-07
- Public Version Status
- New
- Public Device Record Key
- 5719b1c3-a7f0-40d7-9b68-c90ef31e674c
Device Description
5mm, 33cm, Curved Micro Laparoscopy Grasper, 3mm dia. curved double action jaw, stainless steel shaft, stainless steel handle with spring, rigid one piece with flush port.
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35080 | Rigid endoscopic tissue manipulation forceps, reusable | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G453335220506BA0 | HIBCC |