Endo Assist Gray
- Primary DI
- 00840161302014
- Brand
- Endo Assist Gray
- Company
- ZIRC DENTAL PRODUCTS, INC.
- Model
- 50Z460I
- Device description
- "Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect"
- Published
- 2022-10-05
- 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
- false
Product Codes
| Code | Name |
|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840161302014 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840161302014 | 00840161302014 | 840161302014 | 0840161302014 |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument guard, reusable | A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 41.3 | Millimeter |
| Length | 38.1 | Millimeter |
| Width | 44.5 | Millimeter |
Regulatory Flags
- DUNS number
- 064783913
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00840161301468 | Steri-Endo Guard - Endo Holder - Hand - White - 1 Count | 50Z450A | 50Z450A | 2026-02-14 |
| 00840161301475 | Steri-Endo Guard - Endo Holder - Hand - Blue - 1 Count | 50Z450B | 50Z450B | 2026-02-14 |
| 00840161301482 | Steri-Endo Guard - Endo Holder - Hand - Green - 1 Count | 50Z450D | 50Z450D | 2026-02-14 |
| 00840161301499 | Steri-Endo Guard - Endo Holder - Hand - Beige - 1 Count | 50Z450G | 50Z450G | 2026-02-14 |
| 00840161301505 | Steri-Endo Guard - Endo Holder - Hand - Gray - 1 Count | 50Z450I | 50Z450I | 2026-02-14 |
| 00840161301512 | Steri-Endo Guard - Endo Holder - Hand - Plum - 1 Count | 50Z450E | 50Z450E | 2026-02-14 |
| 00840161301529 | Steri-Endo Guard - Endo Holder - Hand - Teal - 1 Count | 50Z450J | 50Z450J | 2026-02-14 |
| 00840161301536 | Steri-Endo Guard - Endo Holder - Hand - Red - 1 Count | 50Z450M | 50Z450M | 2026-02-14 |
| 00840161301543 | Steri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count | 50Z450T | 50Z450T | 2026-02-14 |
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