NA
- Primary DI
- 10724995192577
- Brand
- NA
- Company
- STERIS CORPORATION
- Model
- Lighthandle Cover
- Catalog number
- LB44
- Device description
- The STERIS Disposable Lighthandle Covers are sterilizable consumables (disposable, single-use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment.
- Published
- 2021-04-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10724995192577 | Package | GS1 | 30 | In Commercial Distribution |
| 50724995192575 | Package | GS1 | 4 | In Commercial Distribution |
| 00724995192570 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10724995192577 | 10724995192577 | | |
| 50724995192575 | 50724995192575 | | |
| 00724995192570 | 00724995192570 | 724995192570 | 0724995192570 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep dry and keep from sunlight |
Regulatory Flags
- DUNS number
- 036985604
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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