FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10810030860249
·
Model: MCM107
·
MID CENTRAL MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10810030860249
- Version / Model
- MCM107
- Catalog Number
- MCM107
- 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
- 16dd784e-2d93-4ef7-9e6b-421924a9520e
Device Description
Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protect the patient’s face during surgery and also provides a frame for the anesthesia drape. Constructed of durable stainless steel, it attaches to the OR table rail with two stainless steel side rail sockets (MCM-162 sold separately). Top surface measures 18 1/4" by 22 1/4" and the side supports are 24"L to adjust to the desired height. Side supports measure 1/8" x 1". The flat tray portion can be used to support instruments during surgery. Allows full patient access for anesthesia monitoring. Fully welded stainless steel construction makes it easy to clean and durable.
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 |
|---|---|---|---|---|
| 35501 | Anaesthesia screen | A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810030860249 | GS1 |
Customer Contacts
- Phone
- 701-825-6100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 22.25 | Inch | |
| Depth | 18.25 | Inch | |
| Height | 24 | Inch |