FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 04546540995605 · Model: 5130070031 · STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
04546540995605
Version / Model
5130070031
Catalog Number
5130-070-031
Company Name
STRYKER CORPORATION
Labeler DUNS
196548481
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2022-12-12
Public Version Status
Update
Public Device Record Key
ee261dd6-09af-4705-a4b9-7000dfc1a090

Device Description

3.1mm x 19.1mm Straight Router

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

GMDN Terms

Code Name
46269 Cranial bur, single-use

Identifiers

Type ID
Primary 04546540995605

Customer Contacts

Device Sizes

Type Value Unit Text
Length 19.1 Millimeter
Device Size Text, specify Diameter: 3.1 Millimeter