FDA UDI
In Commercial Distribution
🇺🇸 United States
Stryker®
DI: 00748426143757
·
Model: Equipment Drapes
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Stryker®
- Primary DI
- 00748426143757
- Version / Model
- Equipment Drapes
- Catalog Number
- 111320
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-31
- Public Version
- 1
- Public Version Date
- 2025-11-10
- Public Version Status
- New
- Public Device Record Key
- 9667ecf8-e81f-4509-a3fb-b627fb3cbbb9
Device Description
Mako™ Drape Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). 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 |
|---|---|---|---|---|---|---|
| Package | 10748426143754 | GS1 | pack | 10 | In Commercial Distribution | |
| Primary | 00748426143757 | GS1 | ||||
| Package | 20748426143751 | GS1 | case | 1 | In Commercial Distribution |