AccessGUDID - DEVICE: DYONICS POWER (03596010466174)

GUDID

Device Identifier (DI) Information

Brand Name: DYONICS POWER
Version or Model: 7209393
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7209393
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010466174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: DYONICS PWR AO/SYNTHES CHUCK

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?
31048	Surgical drill chuck	A device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAB	SAW, POWERED, AND ACCESSORIES

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: da646d3b-d270-4359-9b36-8b9d6c5613de
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: August 30, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)821-5700
Email: gudid@smith-nephew.com

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