Easy Guard Endoscopy Bite Guard Adult with Head Strap
- Primary DI
- 05055788710349
- Brand
- Easy Guard Endoscopy Bite Guard Adult with Head Strap
- Company
- FLEXICARE MEDICAL LIMITED
- Model
- 032-10-800U
- Published
- 2020-01-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| MNK | Endoscopic Bite Block |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| MNK | Endoscopic Bite Block | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05055788710349 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055788710349 | 05055788710349 | 5055788710349 |
GMDN Terms
| Term | Definition |
|---|---|
| Seizure bite block | A non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 504406273
- 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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 05055788721550 | Flexicare | 040-835U | 2024-11-21 | |
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| 15055788722585 | BriteBlade Pro Evo Single-Use Fiber Optic Mac 2 | 040-753U | 2024-08-07 | |
| 15055788722608 | BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 | 040-752U | 2024-08-07 | |
| 15055788722622 | BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 | 040-751U | 2024-08-07 | |
| 05055931127888 | Flexicare | 032-10-180LU | 2024-07-17 | |
| 05055931127895 | Flexicare | 032-10-181LU | 2024-07-17 | |
| 05055931127901 | Flexicare | 032-10-182LU | 2024-07-17 | |
| 05055931127918 | Flexicare | 010-762LU | 2024-07-17 | |
| 05055931104162 | ProVu | 040-08-0420U | 2024-06-24 |
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| 06926839800595 | Anrei | Anrei Medical(HZ) Co.,Ltd. | MNK | 2025-01-07 |
| 40884389151151 | MEDLINE | MEDLINE INDUSTRIES, INC. | MNK | 2024-09-20 |
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| 14897129990755 | CeroFrict | SML Med-Tech Solutions Limited | MNK | 2023-12-27 |
| 14897129990762 | CeroFrict | SML Med-Tech Solutions Limited | MNK | 2023-12-27 |
| 14897129990724 | CeroFrict | SML Med-Tech Solutions Limited | MNK | 2023-10-24 |
| 14897129990731 | CeroFrict | SML Med-Tech Solutions Limited | MNK | 2023-10-24 |
| 00620974001072 | Bite Block | Southmedic Incorporated | MNK | 2023-06-23 |
| 00620974001089 | Bite Block | Southmedic Incorporated | MNK | 2023-06-23 |
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