FDA UDI
In Commercial Distribution
🇺🇸 United States
PCL Retractor
DI: B046BIO110830
·
Model: N/A
·
SIGNAL MEDICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PCL Retractor
- Primary DI
- B046BIO110830
- Version / Model
- N/A
- Catalog Number
- BIO-1-1083
- Company Name
- SIGNAL MEDICAL CORPORATION
- Labeler DUNS
- 169289308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-21
- Public Version
- 1
- Public Version Date
- 2023-03-01
- Public Version Status
- New
- Public Device Record Key
- 3e28449f-d129-4a02-a1e7-fcc83590a5d2
Device Description
PCL Retractor
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 |
|---|---|---|---|---|
| KIL | Positioner, Socket | Orthopedic | 888.4540 | 1 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55836 | Leg procedure positioner | A preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B046BIO110830 | HIBCC |
Customer Contacts
- Phone
- 8103647070
- [email protected]