DJO SURGICAL
- Primary DI
- 00888912147392
- Brand
- DJO SURGICAL
- Company
- DJO, LLC
- Model
- 804-02-053
- Device description
- RSP, IMPACTION FIXTURE
- Published
- 2024-05-29
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| HWA | IMPACTOR |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWA | Impactor | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00888912147392 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00888912147392 | 00888912147392 | 888912147392 | 0888912147392 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic implant impactor, reusable | A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 081840873
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- No natural rubber latex
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00190446780601 | CHATTANOOGA | 81-5010 | 2023-04-25 | |
| 00190446780618 | CHATTANOOGA | 81-5011 | 2023-04-25 | |
| 00190446750598 | CHATTANOOGA | 4738 | 2022-09-02 | |
| 00190446750604 | CHATTANOOGA | 4782 | 2022-09-02 | |
| 00190446757214 | CHATTANOOGA | 4782-1 | 2022-09-02 | |
| 00190446757221 | CHATTANOOGA | 4738-1 | 2022-09-02 | |
| 00888912036627 | PROCARE | 79-89200 | 2022-08-22 | |
| 00888912292856 | CHATTANOOGA | 2761-10 | 2016-09-15 | |
| 00888912292863 | CHATTANOOGA | 2761-2 | 2016-09-15 | |
| 00888912294249 | CHATTANOOGA | 2789-10 | 2016-09-15 | |
| 00888912294256 | CHATTANOOGA | 2789-2 | 2016-09-15 | |
| 00888912296977 | CHATTANOOGA | 2874 | 2016-09-15 | |
| 00888912297110 | CHATTANOOGA | 2876 | 2016-09-15 | |
| 00888912297295 | CHATTANOOGA | 2878 | 2016-09-15 | |
| 00888912335652 | CHATTANOOGA | 39-0701 | 2016-09-15 | |
| 00888912335669 | CHATTANOOGA | 39-0702 | 2016-09-15 | |
| 00888912267588 | CHATTANOOGA | 2025 | 2026-03-31 | |
| 00888912267618 | CHATTANOOGA | 2027 | 2026-03-31 | |
| 00888912267625 | CHATTANOOGA | 2028 | 2026-03-31 | |
| 00888912267632 | CHATTANOOGA | 2029 | 2026-03-31 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840286860406 | Tahoe Unicompartmental Knee System | Shalby Advanced Technologies, Inc. | HWA | 2026-07-09 |
| 00885556925690 | NA | Smith & Nephew, Inc. | HWA | 2026-06-04 |
| 10603295543718 | ATTUNE | DEPUY (IRELAND) | HWA | 2025-10-31 |
| 10603295543725 | ATTUNE | DEPUY (IRELAND) | HWA | 2025-10-31 |
| 00841732162709 | GENERIC Surgical Instruments | CTL Medical Corporation | HWA | 2023-09-27 |
| 00841732162716 | GENERIC Surgical Instruments | CTL Medical Corporation | HWA | 2023-09-27 |
| 07613327538601 | INSTRUMENT | Howmedica Osteonics Corp. | HWA | 2023-06-30 |
| 10603295549581 | INHANCE | DEPUY (IRELAND) | HWA | 2023-02-28 |
| 10603295539346 | INHANCE | DEPUY (IRELAND) | HWA | 2021-08-30 |
| 07630055302458 | Offset Cup Impactor - M8x1 interface | Incipio Devices SA | HWA | 2020-04-23 |
| 07630055302465 | Offset Cup Impactor - M10x1.5 interface | Incipio Devices SA | HWA | 2020-04-23 |
| 07640178983052 | JULIET ® INSTRUMENTATION | SpineArt SA | HWA | 2019-02-01 |
| 10705034717364 | NA | Synthes GmbH | HWA | 2019-01-18 |
| 10603295423324 | ATTUNE | DEPUY (IRELAND) | HWA | 2018-09-24 |
| M684201620111 | MICROPORT | Microport Orthopedics Inc. | HWA | 2018-09-13 |
| 10705034720883 | NA | SYNTHES (U.S.A.) LP | HWA | 2018-08-17 |
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| 10381780266389 | Integra™Allograft Wedge System | Ascension Orthopedics, Inc. | HWA | 2018-04-13 |
| 10381780282457 | Integra® PyroCarbon | Ascension Orthopedics, Inc. | HWA | 2018-04-13 |
| 10381780279495 | K2™ Hemi Toe Implant System | Ascension Orthopedics, Inc. | HWA | 2018-04-10 |
| 10381780279907 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | HWA | 2018-04-10 |
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| 10381780224846 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HWA | 2018-03-23 |
| 10381780224853 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HWA | 2018-03-23 |
| 10381780224860 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HWA | 2018-03-23 |
| 10381780224877 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HWA | 2018-03-23 |
| 10381780224884 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | HWA | 2018-03-23 |