FDA UDI In Commercial Distribution 🇺🇸 United States

Reprocessed 2.0mm Drill Bit, 65mm

DI: B3903102011 · Model: 310.201 · SURETEK MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Reprocessed 2.0mm Drill Bit, 65mm
Primary DI
B3903102011
Version / Model
310.201
Company Name
SURETEK MEDICAL
Labeler DUNS
785616934
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-16
Public Version
1
Public Version Date
2021-04-26
Public Version Status
New
Public Device Record Key
c300d89d-82a5-4ffc-a8ec-c880ee4a87b6

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
HTW Bit, Drill

GMDN Terms

Code Name
43390 Fluted surgical drill bit, single-use

Identifiers

Type ID
Primary B3903102011