Stellaris Illumination Adapter
- Primary DI
- 00840096208290
- Brand
- Stellaris Illumination Adapter
- Company
- KATALYST SURGICAL LLC
- Model
- RLP-S
- Device description
- Stellaris Illumination Adapter
- Published
- 2020-06-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| MPA | Endoilluminator |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K140362 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840096208290 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840096208290 | 00840096208290 | 840096208290 | 0840096208290 |
GMDN Terms#
| Term | Definition |
|---|---|
| Light source adaptor | A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 007883297
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
- false
- Sterilization required before use
- true
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