FDA UDI
In Commercial Distribution
🇺🇸 United States
PEAK MEDICAL
DI: G453331801160
·
Model: 33-18-0116
·
Peak Medical Distribution Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PEAK MEDICAL
- Primary DI
- G453331801160
- Version / Model
- 33-18-0116
- Company Name
- Peak Medical Distribution Inc.
- Labeler DUNS
- 078393632
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-24
- Public Version
- 1
- Public Version Date
- 2023-06-01
- Public Version Status
- New
- Public Device Record Key
- defca76b-fa25-4998-bc75-09ea6cf9c61d
Device Description
Curved Flat Blade Wood’s Retractor with contoured tip and handle, overall length 29 cm (11.5"), 24mm (0.95") width. Autoclavable Medical Grade Stainless Steel hardened to specifications.
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
- No
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46774 | Surgical retractor/retraction system blade, reusable | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G453331801160 | HIBCC |