FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark
DI: 00841709117657
·
Model: 9A82001-845
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark
- Primary DI
- 00841709117657
- Version / Model
- 9A82001-845
- Catalog Number
- 9A82001-845
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-06
- Public Version
- 1
- Public Version Date
- 2020-05-14
- Public Version Status
- New
- Public Device Record Key
- 1e81caf8-ec28-4000-bc5d-19392b24060b
Device Description
The Midmark Hand Surgery Armboard, Lunar Gray colored upholstery, is intended to be used with the 230, 630 and 641 Procedure Chairs, and attaches to either side of the chair and supports the patient's arm during procedures on the upper extremities. The adjustable leg extends to the floor for increased stability while the attachment clamp allows for rotary adjustment of the armboard.
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
- Yes
- 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 |
|---|---|---|---|---|
| GBB | CHAIR, SURGICAL, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37047 | Arm procedure positioner, reusable | A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709117657 | GS1 |
Customer Contacts
- Phone
- +1(800)643-6275
- [email protected]