AccessGUDID - DEVICE: CODMAN (10886704036050)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN
Version or Model: 80-1197
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 801197
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704036050
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN Disposable ICP Kit, Plastic, Pediatric CONTENTS: 1 ICP Plastic Screw, 1 Spacing Washer, 1 Handle 1 Retractor, 1 Allen Wrench, 1 5cc Syringe with 22ga x 1.5 Inches 1 Drill Assembly, 1 18ga Spinal Needle 3 Inches, 1 1cc Syringe with 25ga x 5/8 Inch 1 Obturator, 8 4 x 4 Gauze, 1 Bone Wax 2.5gms 1 Male Luer Lock Cap 1 Number 15 Disposable Scalpel 2 Disposable Forceps, 2 Drapes(18 Inches x 26 Inches),1 Fenestrated Drape (24 Inches x 26 Inches)

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?
61401	Intracerebral catheter cranial-fixation kit	A collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K853770	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
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00756b3c-9120-4570-a7db-818bc3443123
Public Version Date: September 15, 2023
Public Version Number: 6
DI Record Publish Date: June 30, 2016