FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10810030863431
·
Model: MCM554-DRAPE
·
MID CENTRAL MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- NA
- Primary DI
- 10810030863431
- Version / Model
- MCM554-DRAPE
- Catalog Number
- MCM554-DRAPE
- Company Name
- MID CENTRAL MEDICAL CORP.
- Labeler DUNS
- 076907973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-03-01
- Public Version
- 1
- Public Version Date
- 2023-03-09
- Public Version Status
- New
- Public Device Record Key
- a360808c-499c-4d2a-9b3d-a2b2c10aacab
Device Description
Sterile Drape for MCM 2-Tier Back Table, 30 x 48" with upper shelf, 12 per case. Single use only.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810030863434 | GS1 | ||||
| Primary | 10810030863431 | GS1 |
Customer Contacts
- Phone
- 701-825-6100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 50 | Inch | |
| Length | 76 | Inch |