Gantry Guard Flex
- Primary DI
- 10687225648889
- Brand
- Gantry Guard Flex
- Company
- PRECISION DYNAMICS CORPORATION
- Model
- CTG02
- Catalog number
- CTG02
- Device description
- Gantry Guard Flex, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 170 x 82 inches, Clear, 15/Box
- Published
- 2018-04-25
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|---|---|---|
| 10687225648889 | Primary | GS1 | 0 | |
| 80687225648888 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10687225648889 | 10687225648889 |
| 80687225648888 | 80687225648888 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 008486367
- Device count
- 15
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10687225799024 | Duraholder | Y5647877 | PDC-DURA100/100 | 2024-01-16 |
| 10687225799031 | Duraholder | Y5647878 | PDC-DURA102/100 | 2024-01-16 |
| 10687225799048 | Duraholder | Y5647879 | PDC-DURA300/100 | 2024-01-16 |
| 10687225799062 | Duraholder | Y5647881 | PDC-DURA505/100 | 2024-01-16 |
| 10687225799079 | Duraholder | Y5647882 | PDC-DURA512/100 | 2024-01-16 |
| 10687225799086 | Duraholder | Y5647883 | PDC-DURA702/100 | 2024-01-16 |
| 10687225325087 | Gantry Guard | CTG01 | 2016-07-28 | |
| 10687225488560 | Gantry Guard | SCTG01 | 2016-07-28 | |
| 10687225677865 | Gantry Guard Flex Mini | CTG03 | CTG03 | 2018-04-25 |
| 10687225704615 | Gantry Guard Flex | PSCTCVR2 | 2019-01-08 | |
| 10687225704622 | Gantry Guard Flex Mini | PSCTCVR3 | 2019-01-08 | |
| 10687225799185 | Duraholder | Y5647877 | PDC-DURA100/100 | 2024-01-16 |
| 10687225799192 | Duraholder | Y5647878 | PDC-DURA102/100 | 2024-01-16 |
| 10687225799208 | Duraholder | Y5647879 | PDC-DURA300/100 | 2024-01-16 |
| 10687225799222 | Duraholder | Y5647881 | PDC-DURA505/100 | 2024-01-16 |
| 10687225799239 | Duraholder | Y5647882 | PDC-DURA512/100 | 2024-01-16 |
| 10687225799246 | Duraholder | Y5647883 | PDC-DURA702/100 | 2024-01-16 |
| 10687225793756 | PEDIATRIC URINE COLLECTORS, STERILE | 05002 | 05002-00-SSB (Y5178898) | 2023-06-20 |
| 10687225793749 | PEDIATRIC URINE COLLECTORS, CLEAN | 05001 | 05001-00-SCB (Y5178897) | 2023-06-20 |
| 10687225793596 | PEDIATRIC URINE COLLECTORS, STERILE | 05002 | 05002-00-SSB (Y5178898) | 2023-06-20 |
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| 00197998305030 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
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| 00197998305092 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
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