FDA UDI
In Commercial Distribution
🇺🇸 United States
Morzine Medical
DI: 00860006920708
·
Model: Doak MK4
·
Morzine Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Morzine Medical
- Primary DI
- 00860006920708
- Version / Model
- Doak MK4
- Company Name
- Morzine Medical LLC
- Labeler DUNS
- 079098440
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-21
- Public Version
- 1
- Public Version Date
- 2021-07-29
- Public Version Status
- New
- Public Device Record Key
- 68c116b8-6dc9-4a6a-bd4d-5128b366a6ce
Device Description
The Doak Table™ is a portable field surgical table that deploys within 60 seconds to receive a standard military litter. The base tableweighs between 41 –45lbs depending on configurationand will foldto dimensions of 41” x 12” x 15”. The table will accommodate a litter weight in excess of 400 lbs. The base table is a single, fully-integrated unit with no loose pieces that can be erected without tools.Other features include height adjustability and the ability place a patient in Trendelenburg or reverse-Trendelenburg position. Arm boards, IV poles, surgical instrument trays and avariety of feet/wheels are available to customize the table to the user’s exact requirements. The standard accessories package weighs less than 32 lbs.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FSE | Table, Operating-Room, Manual | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34873 | Manual hospital bed | A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006920708 | GS1 |