FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rex Mallet
DI: D894040001310
·
Model: Rex Mallet
·
Rex Implants, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rex Mallet
- Primary DI
- D894040001310
- Version / Model
- Rex Mallet
- Catalog Number
- 04000131
- Company Name
- Rex Implants, Inc.
- Labeler DUNS
- 080746478
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-07
- Public Version
- 6
- Public Version Date
- 2026-03-12
- Public Version Status
- Update
- Public Device Record Key
- c31d31a9-1e37-4e80-a5dd-cec50bf38d9a
- Distribution End Date
- 2026-03-04
Device Description
Package includes Rex Mallet Console and the following individually packaged accessories: Rex Mallet Handpiece, Rex Mallet Foot Pedal, P. Striker / Remover, Wrench (not a medical device), and Rex Mallet Handpiece Holder (not a medical device)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32856 | Orthopaedic implant impactor, reusable | A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D894040001310 | HIBCC | ||||
| Package | D894052000021010 | HIBCC | Conveniece kit | 1 | Not in Commercial Distribution | 2026-03-04 |
Customer Contacts
- Phone
- 6146538429
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 70 Degrees Celsius