AccessGUDID - DEVICE: SURGAIRTOME TWO (10845854044971)

GUDID

Device Identifier (DI) Information

Brand Name: SURGAIRTOME TWO
Version or Model: 5058-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5058-001
Company Name: Conmed Corporation

Primary DI Number: 10845854044971
Issuing Agency: GS1
Commercial Distribution End Date: April 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SURGAIRTOME TWO HANDPIECE

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?
37841	Surgical power tool system handpiece, sawing, pneumatic	A pneumatically-powered, hand-held device that consists of a motorized handpiece that provides sagittal, oscillating, or reciprocating movement for attachable serrated blades to cut through hard/tough tissue during surgery. The device may be of the micro or macro design and is typically powered by a compressed gas [e.g., surgical-grade air or nitrogen (N2)]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K781979	000

Device Exempt from Premarket Submission: No 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: ccb63753-dfef-4d6e-9859-5727b203a892
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016