MolecuLightDX DarkDrape
- Primary DI
- 00628110259394
- Brand
- MolecuLightDX DarkDrape
- Company
- MolecuLight Inc
- Model
- 1973
- Device description
- Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX.
- Published
- 2022-01-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PUI | Drape, Surgical, Exempt |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00628110259400 | Package | GS1 | 50 | In Commercial Distribution |
| 00628110259394 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00628110259400 | 00628110259400 | 628110259400 | 0628110259400 |
| 00628110259394 | 00628110259394 | 628110259394 | 0628110259394 |
GMDN Terms#
| Term | Definition |
|---|---|
| Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. |
Regulatory Flags#
- DUNS number
- 202822052
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00628110259530 | MolecuLightDX+ System | 2635 | 2026-07-08 | |
| 00628110259448 | MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25 | 2096 | 2026-07-08 | |
| 00628110259547 | Thermal Imaging Module | 2640 | 2026-07-08 | |
| 00628110259554 | MolecuLightDX Eco DarkDrapes (Case of 50) | 2517 | 2026-07-08 | |
| 00628110259578 | MolecuLightDX DarkDrape Eco Clip | 2393 | 2026-07-08 | |
| 00628110259585 | MolecuLightDX+ Thermal Eco Clip | 2395 | 2026-07-08 | |
| 00628110259295 | MolecuLight DarkDrape | 1426 | 2022-01-05 | |
| 00628110259363 | i:X Sterile Surgical Sleeve Convenience Kit | 1859 | 2022-01-05 | |
| 00628110259325 | MolecuLight i:X System | 1153-11 | 2022-01-04 | |
| 00628110259387 | MolecuLightDX System | 2094 | 2022-01-04 |
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