Duns Number:607846297
Device Description: CODMAN Disposable ICP Kit, Plastic, Pediatric CONTENTS: 1 ICP Plastic Screw, 1 Spacing Was 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)
Catalog Number
801197
Brand Name
CODMAN
Version/Model Number
80-1197
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
00756b3c-9120-4570-a7db-818bc3443123
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
June 30, 2016
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |