AccessGUDID - DEVICE: ULTRAPOWER (10845854023952)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRAPOWER
Version or Model: 00702002300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7020-023
Company Name: Conmed Corporation

Primary DI Number: 10845854023952
Issuing Agency: GS1
Commercial Distribution End Date: June 04, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 20 DEG ANGLE ATTACHMENT WITH LUBRICANT

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?
43962	Drilling power tool attachment, basic	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. 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
Angle: 20 degree

Device Record Status

Public Device Record Key: 1f367d3f-3126-4e97-8415-11d4345ab26e
Public Version Date: June 05, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2020