FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Loop-X Source Drape (1 Pc)
DI: 04056481146009
·
Model: 22183-12
·
Brainlab SE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Loop-X Source Drape (1 Pc)
- Primary DI
- 04056481146009
- Version / Model
- 22183-12
- Company Name
- Brainlab SE
- Labeler DUNS
- 314482980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-25
- Public Version
- 2
- Public Version Date
- 2025-09-17
- Public Version Status
- Update
- Public Device Record Key
- 7a5ef19e-ea20-4a6c-a213-032b855c8660
Device Description
The source drape is intended to sterile cover the source (cone beam) of the Loop-X.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 04056481145941 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04056481146009 | GS1 |