Equinoxe
- Primary DI
- 10885862243997
- Brand
- Equinoxe
- Company
- Exactech, Inc.
- Model
- 320-15-10
- Catalog number
- 320-15-10
- Device description
- Low Profile Locking Cap
- Published
- 2018-10-29
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K180632 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10885862243997 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10885862243997 | 10885862243997 |
GMDN Terms#
| Term | Definition |
|---|---|
| Shoulder prosthesis screw | A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Regulatory Flags#
- DUNS number
- 157565946
- Device count
- 1
- Serial number
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10885862094780 | OpteCure | 650-00-01 | 650-00-01 | 2016-07-17 |
| 10885862094797 | OpteCure | 650-00-02 | 650-00-02 | 2016-07-17 |
| 10885862094803 | OpteCure | 650-00-05 | 650-00-05 | 2016-06-17 |
| 10885862094810 | OpteCure | 650-00-10 | 650-00-10 | 2016-07-17 |
| 10885862094827 | Optecure | 650-00-20 | 650-00-20 | 2016-09-19 |
| 10885862094841 | OpteCure+CCC | 652-00-01 | 652-00-01 | 2016-07-17 |
| 10885862094858 | OpteCure+CCC | 652-00-02 | 652-00-02 | 2016-07-17 |
| 10885862094865 | OpteCure+CCC | 652-00-05 | 652-00-05 | 2016-07-17 |
| 10885862094872 | OpteCure+CCC | 652-00-10 | 652-00-10 | 2016-07-17 |
| 10885862094889 | OpteCure+CCC | 652-00-20 | 652-00-20 | 2016-07-17 |
| 10885862095039 | Ossigen | 660-00-20 | 660-00-20 | 2016-07-17 |
| 10885862252593 | Entice +CCC | 692-00-01 | 692-00-01 | 2016-07-17 |
| 10885862252609 | Entice +CCC | 692-00-02 | 692-00-02 | 2016-07-17 |
| 10885862252616 | Entice +CCC | 692-00-05 | 692-00-05 | 2016-07-17 |
| 10885862252623 | Entice +CCC | 692-00-10 | 692-00-10 | 2016-07-17 |
| 10885862252630 | Entice +CCC | 692-00-20 | 692-00-20 | 2016-07-17 |
| 10885862252845 | Entice | 690-00-01 | 690-00-01 | 2016-07-17 |
| 10885862252852 | Entice | 690-00-02 | 690-00-02 | 2016-07-17 |
| 10885862252869 | Entice | 690-00-05 | 690-00-05 | 2016-07-17 |
| 10885862252876 | Entice | 690-00-10 | 690-00-10 | 2016-07-17 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840097503677 | Veritas Instrumentation | Restor3d, Inc. | PHX | 2026-10-16 |
| 07630699705950 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699705967 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699705974 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699705998 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699706001 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699706018 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699706032 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699706049 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| 07630699706056 | Shoulder System | Medacta International SA | PHX | 2026-10-01 |
| B1132R2HC300100 | Shoulder Innovations RSA Glenosphere Trial Instrument Case | Shoulder Innovations, Inc. | PHX | 2026-09-30 |
| 07630345775320 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630345775375 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542727528 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542727535 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542727542 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542727559 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795008 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795015 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795022 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795039 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795046 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795053 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795060 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795077 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795084 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795091 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795107 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795114 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |
| 07630542795121 | Shoulder System | Medacta International SA | PHX | 2026-09-28 |