AccessGUDID - DEVICE: NA (20845854019051)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 55SPH-EL-ST
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 55SPH-EL-ST
Company Name: Conmed Corporation

Primary DI Number: 20845854019051
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5.5MM x 19CM STERLING SPHERICAL BUR, EXTENDED LENGTH

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:	Yes
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?
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5.5 Millimeter
Length: 19 Centimeter

Device Record Status

Public Device Record Key: 8d4dbe44-0d6d-41ef-836f-c465b6e9f8c8
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2020