Identity
- Trade Name
- CODMAN FDA UDI
- Generic Name
- Intracerebral catheter cranial-fixation kit FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- 80-1197 FDA UDI
- 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) FDA UDI
Identifiers
- Catalog Number
- 801197 FDA UDI
- Primary DI / UDI-DI
- 10886704036050 FDA UDI
- 510(k) Number
- K853770 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracerebral catheter cranial-fixation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Codman by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K853770 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA UDI 00756b3c-9120-4570-a7db-818bc3443123 38 fields · synced Jun 8, 2026