Model: SNE51CRKKU
Catalog: SNE51CRKKU
DI: 10198956416093
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
CRANIOTOMY, MORSE AVE PACK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e8ed90e0-256d-4008-a2cf-d5bb7c1a190e
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50198956416091
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956416093
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956416093
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 56302
Name: Craniotomy kit
Definition:
A collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
OJG
Neurological tray
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature