Duns Number:081277700
Device Description: Disposable ICP Kit, Plastic, Adult CONTENTS: 1 ICP Screw, 2 Spacing Washers, 1 Handle 1 Re Disposable ICP Kit, Plastic, Adult CONTENTS: 1 ICP Screw, 2 Spacing Washers, 1 Handle 1 Retractor, 1 5cc Syringe with 22ga x 1.5 Inches, 1 Drill Assembly 1 Obturator, 1 18ga Spinal Needle 3 Inches, 1 1cc Syringe with 25ga x 5/8 Inch 1 Allen Wrench, 2 Disposable Forceps, 2 Drapes (18 Inches x 26 Inches) 8 4 x 4 Gauze, 1 Bone Wax 2.5gms, 1 Male Luer Lock Cap 1 Number 15 Disposable Scalpel, 1 Fenestrated Drape (24 Inches x 26 Inches)
Catalog Number
80-1196
Brand Name
CODMAN®
Version/Model Number
801196
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K853770
Product Code
GWM
Product Code Name
Device, monitoring, intracranial pressure
Public Device Record Key
370866db-77d9-48db-83d4-667eb41e432a
Public Version Date
May 13, 2021
Public Version Number
2
DI Record Publish Date
April 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |