FDA UDI
In Commercial Distribution
🇺🇸 United States
CT Gantry Cover
DI: 07640178062023
·
Model: CT Gantry Cover S47
·
Pearl Technology AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CT Gantry Cover
- Primary DI
- 07640178062023
- Version / Model
- CT Gantry Cover S47
- Catalog Number
- 1310
- Company Name
- Pearl Technology AG
- Labeler DUNS
- 480151859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-17
- Public Version
- 1
- Public Version Date
- 2025-12-25
- Public Version Status
- New
- Public Device Record Key
- 1c0ab2ed-7727-46dc-aff5-e649f93d8f93
Device Description
Reusable hygienic device shield for CT devices during invasive and non-invasive procedures to protect the CT device from penetrating fluids. Covers the lower half of the CT gantry. May only be used by medical personnel. Non-sterile and not to be used in the sterile field.
Device Characteristics
- Single Use
- No
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | 880.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58976 | Medical equipment/instrument drape, reusable | A noninvasive 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 is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640178062023 | GS1 |