EMERGE MEDICAL & Design
- Primary DI
- 00886020028664
- Brand
- EMERGE MEDICAL & Design
- Company
- EMERGE MEDICAL, INC.
- Model
- 323.029.EM
- Catalog number
- 323.029.EM
- Device description
- 1.8MM THREADED DRILL GUIDE, WITH DEPTH GAUGE
- Published
- 2015-07-08
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00886020028664 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00886020028664 | 00886020028664 | 886020028664 | 0886020028664 |
GMDN Terms#
| Term | Definition |
|---|---|
| Surgical drill guide, reusable | A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 078642955
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00886020026424 | EMERGE MEDICAL & Design | 319.289.EM | 319.289.EM | 2015-07-08 |
| 00886020026448 | EMERGE MEDICAL & Design | 319.291.EM | 319.291.EM | 2015-07-08 |
| 00886020026462 | EMERGE MEDICAL & Design | 319.25.EM | 319.25.EM | 2015-07-08 |
| 00886020026493 | EMERGE MEDICAL & Design | 319.26.EM | 319.26.EM | 2015-07-08 |
| 00886020026578 | EMERGE MEDICAL & Design | 319.24.EM | 319.24.EM | 2015-07-08 |
| 00886020028916 | EMERGE MEDICAL & Design | 398.95.EM | 398.95.EM | 2015-07-08 |
| 00886020028923 | EMERGE MEDICAL & Design | 399.091.EM | 399.091.EM | 2015-07-08 |
| 00886020026417 | EMERGE MEDICAL & Design | 319.293.EM | 319.293.EM | 2015-07-08 |
| 00886020026431 | EMERGE MEDICAL & Design | 319.292.EM | 319.292.EM | 2015-07-08 |
| 00886020026455 | EMERGE MEDICAL & Design | 319.38.EM | 319.38.EM | 2015-07-08 |
| 00886020026479 | EMERGE MEDICAL & Design | 319.35.EM | 319.35.EM | 2015-07-08 |
| 00886020026554 | EMERGE MEDICAL & Design | 319.46.EM | 319.46.EM | 2015-07-08 |
| 00886020026899 | EMERGE MEDICAL & Design | 309.501.EM | 309.501.EM | 2015-07-08 |
| 00886020026677 | EMERGE MEDICAL & Design | 319.70.EM | 319.70.EM | 2015-07-08 |
| 00886020026684 | EMERGE MEDICAL & Design | 311.689.EM | 311.689.EM | 2015-07-08 |
| 00886020026998 | EMERGE MEDICAL & Design | 319.703.EM | 319.703.EM | 2015-07-08 |
| 00886020028602 | EMERGE MEDICAL & Design | 319.004.EM | 319.004.EM | 2015-07-08 |
| 00886020028619 | EMERGE MEDICAL & Design | 319.006.EM | 319.006.EM | 2015-07-08 |
| 00886020028657 | EMERGE MEDICAL & Design | 323.025.EM | 323.025.EM | 2015-07-08 |
| 00886020030308 | EMERGE MEDICAL & Design | 319.01.EM | 319.01.EM | 2015-07-08 |
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