AccessGUDID - DEVICE: NA (10886982007407)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: SD516.324
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SD516324
Company Name: SYNTHES (U.S.A.) LP

Primary DI Number: 10886982007407
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 832637081 *Terms of Use

Device Description: EX NAIL POWER ADAPTER

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?
44641	Multi-purpose surgical power tool system, rechargeable battery-powered	An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: 525994e3-2e0d-4d06-8ca5-1cabbf079a29
Public Version Date: December 03, 2018
Public Version Number: 5
DI Record Publish Date: December 31, 2016