FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10810030860454
·
Model: MCM611
·
MID CENTRAL MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10810030860454
- Version / Model
- MCM611
- Catalog Number
- MCM611
- Company Name
- MID CENTRAL MEDICAL CORP.
- Labeler DUNS
- 076907973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 1
- Public Version Date
- 2020-09-09
- Public Version Status
- New
- Public Device Record Key
- 382c1b30-d13c-46ff-87df-16e4e42c6a25
Device Description
SS Pickett Fence Leg Holder. The Picket Fence Leg Prep Unit efficiently preps one or two legs at a time. It has a 5/8" diameter, stainless steel support bar adjusts easily up to 30". The Picket Fence Leg Prep Unit is easy to clean. Attaches to OR Table rail with clark socket (sold separately). Top portion is covered in urethane for protection and easy cleaning. With only one support, leaves extra open space under and around the unit. .
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | 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 | 10810030860454 | GS1 |
Customer Contacts
- Phone
- 701-825-6100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 19 | Inch | |
| Depth | 0.625 | Inch | |
| Height | 30 | Inch |