FDA UDI In Commercial Distribution 🇺🇸 United States

Reprocessed Small Bone Osc Sagittal Blade, 25 x 5.5 x 0.38mm

DI: B390KM34141 · Model: KM3-414 · SURETEK MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Reprocessed Small Bone Osc Sagittal Blade, 25 x 5.5 x 0.38mm
Primary DI
B390KM34141
Version / Model
KM3-414
Company Name
SURETEK MEDICAL
Labeler DUNS
785616934
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-20
Public Version
2
Public Version Date
2024-02-22
Public Version Status
Update
Public Device Record Key
a008db81-407e-44e6-82a5-c29cb50f1ad2

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
Yes
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
GFA Blade, Saw, General & Plastic Surgery, Surgical

GMDN Terms

Code Name
61804 Surgical saw blade, oscillating, reprocessed

Identifiers

Type ID
Primary B390KM34141