FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 50724995156386
·
Model: Lighthandle Cover
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- NA
- Primary DI
- 50724995156386
- Version / Model
- Lighthandle Cover
- Catalog Number
- LB51
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2021-04-02
- Public Version
- 1
- Public Version Date
- 2021-04-12
- Public Version Status
- New
- Public Device Record Key
- a0b2a875-20bb-443a-b622-9233ee5b7d07
Device Description
The STERIS Harmony Surgical Light Handle Cover is a sterilizable consumable (disposable, single use) used to drape the light handle, camera housing, and flat screen monitor handles for the purpose of maintaining a sterile surgical environment.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00724995156381 | GS1 | ||||
| Primary | 50724995156386 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]