FDA UDI
In Commercial Distribution
🇺🇸 United States
The Woodpecker
DI: 07629999033979
·
Model: The Woodpecker
·
IMT Integral Medizintechnik AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Woodpecker
- Primary DI
- 07629999033979
- Version / Model
- The Woodpecker
- Company Name
- IMT Integral Medizintechnik AG
- Labeler DUNS
- 482328465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-23
- Public Version
- 1
- Public Version Date
- 2022-12-01
- Public Version Status
- New
- Public Device Record Key
- ac09a0af-c43d-4d45-b687-1f87a58cb7f3
Device Description
The Woodpecker is a pneumatically powered device whereby the surgeon can create a precisely reamed prosthesis bed in the medullary femur. The minimal impulses generated by the rasp machine reduce tension peaks, fissures and splintering. The low intraosseous pressure minimizes the risk of fat embolism syndrome substantially. The high-frequency axial impulses of the instrument substantially reduce operating time.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58189 | Bone/joint surgical power tool motorized handpiece/set, pneumatic | A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07629999033979 | GS1 |