FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Drape, sterile for motor or footswitch (Straub Medical®)
DI: 07640142810193
·
Model: Version 1.0
·
Straub Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Drape, sterile for motor or footswitch (Straub Medical®)
- Primary DI
- 07640142810193
- Version / Model
- Version 1.0
- Catalog Number
- 80068
- Company Name
- Straub Medical AG
- Labeler DUNS
- 488489766
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-31
- Public Version
- 7
- Public Version Date
- 2025-09-22
- Public Version Status
- Update
- Public Device Record Key
- ef22f639-44de-4fad-a4c3-3309108dcbfd
- Distribution End Date
- 2025-01-28
Device Description
The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- 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/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 |
|---|---|---|---|---|---|---|
| Primary | 07640142810193 | GS1 |
Customer Contacts
- Phone
- +41817200460
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172315 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 18.5 | Centimeter | |
| Length | 340 | Centimeter |