AccessGUDID - DEVICE: CODMAN® (10381780514930)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 801397
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-1397
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780514930
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 081277700 *Terms of Use
Previous DI: 20886704036453

Device Description: CODMAN® Surgical Patties 1/4" x1 1/2" (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
Device Size Text, specify: 0.64cm x 3.81cm
Device Size Text, specify: 1/4 Inch x 1 1/2 Inch

Device Record Status

Public Device Record Key: ec0a6126-a7ad-45cf-9899-171b2a481df0
Public Version Date: June 24, 2025
Public Version Number: 7
DI Record Publish Date: April 01, 2020