ANAX™ 5.5 CT SPINAL SYSTEM
- Primary DI
- 08800037544964
- Brand
- ANAX™ 5.5 CT SPINAL SYSTEM
- Company
- U&I CORPORATION
- Model
- CT0120
- Published
- 2020-11-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HXE | Fork | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800037544964 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800037544964 | 08800037544964 | 8800037544964 |
GMDN Terms
| Term | Definition |
|---|
| Surgical implant/trial-implant/sizer holder, reusable | A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 688811082
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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
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| 00842962170779 | HNM Medical | HNM STAINLESS, LLC. | HXE | 2024-03-07 |
| 00190776337773 | Millennium | AVALIGN TECHNOLOGIES, INC. | HXE | 2023-06-23 |
| 04047844111765 | COSY | SIGNUS Medizintechnik GmbH | HXE | 2023-03-15 |
| 00191083033174 | Cross-Fuse® II PEEK IBF System | Pioneer Surgical Technology, Inc. | HXE | 2022-03-31 |
| B922F00400270 | ACURA Stabilization System - Rod Lever/ Reduction Fork | INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED | HXE | 2022-03-21 |
| 00840192715241 | FAICO CMF System | FAICO MEDICAL LLC | HXE | 2021-04-20 |
| 00840192715548 | FAICO CMF System | FAICO MEDICAL LLC | HXE | 2021-04-20 |
| 04038653164134 | AESCULAP | Aesculap AG | HXE | 2020-07-06 |
| 04046963780128 | ACTIV C | Aesculap AG | HXE | 2020-04-24 |
| 04046963783143 | ACTIV C | Aesculap AG | HXE | 2020-04-24 |
| 04038653403943 | NOVOCART | Aesculap AG | HXE | 2020-04-23 |
| 08800037523969 | ANAX™ 5.5 CT SPINAL SYSTEM | U&I CORPORATION | HXE | 2020-01-12 |
| 08800015999939 | ANAX™ 5.5 CT SPINAL SYSTEM | U&I CORPORATION | HXE | 2019-07-29 |
| 00889024577527 | Extremities | Zimmer, Inc. | HXE | 2019-07-01 |
| 00840019925853 | PSS System | PRECISION SPINE, INC. | HXE | 2019-03-27 |
| 07640139349149 | OTELO INSTRUMENTATION | SpineArt SA | HXE | 2019-02-01 |
| 00888118120144 | FORK | KLS-Martin L.P. | HXE | 2018-11-22 |
| 00846468011208 | Cross-Fuse® II PEEK VBR/IBF System | Pioneer Surgical Technology, Inc. | HXE | 2018-10-06 |
| 00888118064400 | FORK | KLS-Martin L.P. | HXE | 2018-09-26 |
| 24026704291865 | KMEDIC | TELEFLEX INCORPORATED | HXE | 2018-09-15 |
| 08800015951982 | Optima™ Spinal System | U&I CORPORATION | HXE | 2017-11-02 |
| 08800015959438 | OPTIMA™ ZS Spinal System | U&I CORPORATION | HXE | 2017-10-31 |
| 08800015959414 | OPTIMA™ ZS Spinal System | U&I CORPORATION | HXE | 2017-10-31 |
| M697C06700430 | Certex Spinal Fixation System | Xtant Medical Holdings, Inc. | HXE | 2017-04-01 |
| 10889981080419 | Malibu | SEASPINE ORTHOPEDICS CORPORATION | HXE | 2016-05-02 |
| 10889981080426 | Malibu | SEASPINE ORTHOPEDICS CORPORATION | HXE | 2016-05-02 |