FDA UDI Not in Commercial Distribution 🇺🇸 United States

STRADIS

DI: M7526550041 · Model: 655-004 · STRADIS MEDICAL, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
STRADIS
Primary DI
M7526550041
Version / Model
655-004
Catalog Number
655-004
Company Name
STRADIS MEDICAL, LLC
Labeler DUNS
174262477
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-31
Public Version
6
Public Version Date
2023-01-24
Public Version Status
Update
Public Device Record Key
056f7cf4-b10c-47e0-ba70-7bd3a3ad067b
Distribution End Date
2023-01-23

Device Description

DENTAL IMPLANT KIT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No

GMDN Terms

Code Name
33961 General surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary M7526550041