AccessGUDID - DEVICE: N/A (00817438020384)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: CC6-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Omega Surgical Instruments Inc

Primary DI Number: 00817438020384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808825038 *Terms of Use

Device Description: 63.5 MM X 0.89 MM CAST CUTTING / AUTOPSY SEGMENTED ROUND OSCILLATING BLADE (NON-STERILE)

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?
15774	Cast cutter blade	A surgical cutting device intended to be used with a cast removal tool (cast cutter) to provide the cutting edge for cutting through cast material so that this can be removed from the patient. It is formed as a thin, rounded, half moon-like, or circular blade with serrated teeth around its cutting edge. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFA	Blade, Saw, General & Plastic Surgery, Surgical

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 [?]
Radiation 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: ca4b4ba1-08c0-45b0-9e40-14a7ac9dbe36
Public Version Date: July 20, 2022
Public Version Number: 1
DI Record Publish Date: July 12, 2022