FDA UDI
In Commercial Distribution
🇺🇸 United States
Skytron Lite-Lok
DI: 00748426118519
·
Model: B1-020-99-1
·
Microtek Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Skytron Lite-Lok
- Primary DI
- 00748426118519
- Version / Model
- B1-020-99-1
- Catalog Number
- B1-020-99-1
- Company Name
- Microtek Medical Inc.
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 3
- Public Version Date
- 2023-03-22
- Public Version Status
- Update
- Public Device Record Key
- 5de41211-4eca-4ebb-8124-515decfcad7c
Device Description
Disposable Light Handle Cover, Single
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44977 | Medical equipment handle cover, single-use | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00748426118519 | GS1 | ||||
| Package | 30748426118510 | GS1 | 40 | In Commercial Distribution | ||
| Package | 50748426118514 | GS1 | 40 | In Commercial Distribution |