CMR
- Primary DI
- 08682952413835
- Brand
- CMR
- Company
- PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI
- Model
- 20501
- Device description
- Versius Camera Head Drape
- Published
- 2025-08-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- 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 |
|---|---|---|---|---|
| 08682952413835 | Package | GS1 | 10 | In Commercial Distribution |
| 08682952413828 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08682952413835 | 08682952413835 | 8682952413835 |
| 08682952413828 | 08682952413828 | 8682952413828 |
GMDN Terms#
| Term | Definition |
|---|---|
| Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 533130347
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08681756013401 | Pergo | 05TD1370 | 2025-12-26 | |
| 08682952400545 | Pergo | 05TD3605 | 05TD3605 | 2025-12-26 |
| 08681756013425 | Pergo | 05TD1370 | 2025-12-26 | |
| 08682952400569 | Pergo | 05TD3605 | 05TD3605 | 2025-12-26 |
| 08682952411039 | Pergo | SC0405CVL | 2023-12-06 | |
| 08682952420093 | DeRoyal | 71-0046 | 2025-11-06 | |
| 08682952411053 | Pergo | SC0405XVTC | 2023-12-06 | |
| 08682952411121 | Pergo | SC0405CVT | 2023-12-06 | |
| 08682952418144 | DeRoyal | 71-2722 | 2025-05-08 | |
| 08682952410995 | Pergo | SC0405WHA | 2023-12-06 | |
| 08682952411107 | Pergo | SC0405ST | 2023-12-06 | |
| 08682952413750 | CMR | 20102 | 2025-08-20 | |
| 08682952413774 | CMR | 20201 | 2025-08-20 | |
| 08682952413798 | CMR | 20302 | 2025-08-20 | |
| 08682952413811 | CMR | 20401 | 2025-08-20 | |
| 08682952413859 | CMR | 20902 | 2025-08-20 | |
| 08682952419370 | DeRoyal | 71-BG1000-PE | 2025-07-30 | |
| 08682952419394 | DeRoyal | 71-BG1500-PE | 2025-07-30 | |
| 08682952419417 | DeRoyal | 71-BG2000-PE | 2025-07-30 | |
| 08682952419431 | DeRoyal | 71-BG3000-PE | 2025-07-30 |
Other Devices Sharing Product Codes#
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| 00197998192814 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998304996 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305016 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305030 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305078 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305092 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305115 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305139 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305153 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312373 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312397 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312434 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312458 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312472 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998312496 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329678 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329708 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329739 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329760 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329791 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329821 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998329852 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330032 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330124 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330216 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330278 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330308 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330346 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330360 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998330438 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |