FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10810030861437
·
Model: MCM401
·
MID CENTRAL MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10810030861437
- Version / Model
- MCM401
- Catalog Number
- MCM401
- Company Name
- MID CENTRAL MEDICAL CORP.
- Labeler DUNS
- 076907973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 8eaf1c79-b69f-4ae0-99a1-04fe8d5ba383
Device Description
Radiolucent Height Adjustable Armboard with Posi-Lock. This armboard is designed to support patient’s arms during surgery. Large portion of board is also radiolucent for C-arm capabilities. Rotates 180 degrees to desired position. It also adjusts in height to match the top of the OR table or to elevate the patients arm if needed. Adjusts up to 4 in height. Standard size is 6" x 26". Clamps securely to any American made OR table rail. Uses 26" L armboard pad sold separately. .
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 |
|---|---|---|---|---|
| NOD | Board, Arm (With Cover), Non-Sterile | General, Plastic Surgery | 878.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42308 | Operating table orthopaedic extension | An orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810030861437 | GS1 |
Customer Contacts
- Phone
- 701-825-6100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Inch | |
| Length | 26 | Inch | |
| Height | 0.375 | Inch |