AccessGUDID - DEVICE: CODMAN (20886704036453)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN
Version or Model: 80-1397
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 801397
Company Name: Cerenovus, Inc.

Primary DI Number: 20886704036453
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 200
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN Surgical Patties 1/4 Inch x 1 1/2 Inches (0.64cm x 3.81cm)

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?
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBA	NEUROSURGICAL PADDIE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K880402	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d1ac435-a73e-4f39-96a5-5e99c72e5879
Public Version Date: September 15, 2023
Public Version Number: 6
DI Record Publish Date: June 30, 2016