AccessGUDID - DEVICE: The Woodpecker (07629999033979)

GUDID

Device Identifier (DI) Information

Brand Name: The Woodpecker
Version or Model: The Woodpecker
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMT Integral Medizintechnik AG

Primary DI Number: 07629999033979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482328465 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GET	Motor, Surgical Instrument, Pneumatic Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac09a0af-c43d-4d45-b687-1f87a58cb7f3
Public Version Date: December 01, 2022
Public Version Number: 1
DI Record Publish Date: November 23, 2022