FDA UDI Not in Commercial Distribution 🇺🇸 United States

CODMAN

DI: 20886704004285 · Model: 24-5436 · Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

Basic Information

Brand Name
CODMAN
Primary DI
20886704004285
Version / Model
24-5436
Catalog Number
245436
Company Name
Cerenovus, Inc.
Labeler DUNS
607846297
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2016-06-30
Public Version
6
Public Version Date
2023-09-15
Public Version Status
Update
Public Device Record Key
7c471dc5-36c7-4b90-b934-f94ce15d5eee
Distribution End Date
2022-09-01

Device Description

CODMAN Bulk Surgical Strips X-Ray Detectable 2 Inches x 6 Inches (51mm x 152mm)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
HBA NEUROSURGICAL PADDIE

GMDN Terms

Code Name
13702 Neurosurgical sponge

Identifiers

Type ID
Primary 20886704004285
Unit of Use 10886704004288

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K880402 000