FDA UDI
In Commercial Distribution
🇺🇸 United States
Movement®
DI: 10381780246664
·
Model: PPB-890-00
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Movement®
- Primary DI
- 10381780246664
- Version / Model
- PPB-890-00
- Catalog Number
- PPB89000
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-30
- Public Version
- 3
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- cd7a703d-7e0e-4d8b-aecc-55a164707a8a
- Distribution End Date
- 2026-12-31
Device Description
Movement® Great Toe System Proximal Phalanx Broach The Movement Great Toe Proximal Phalanx Broach is used to prepare a cavity that provides a press fit for the implant.
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTQ | BROACH | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36167 | Orthopaedic broach | A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M269PPB890001 | HIBCC | ||||
| Primary | 10381780246664 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.35 in L |