FDA UDI In Commercial Distribution 🇺🇸 United States

Small Bone Tool

DI: M791SBT1000HT0 · Model: SBT1000HT · BIOACCESS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Small Bone Tool
Primary DI
M791SBT1000HT0
Version / Model
SBT1000HT
Company Name
BIOACCESS INC
Labeler DUNS
942203001
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-04
Public Version
1
Public Version Date
2022-08-12
Public Version Status
New
Public Device Record Key
aae29d8f-2ebc-4780-938a-203cfe721e62

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
GFF Bur, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
63566 Bone/joint surgical power tool motorized handpiece/set, electric, single-use

Identifiers

Type ID
Primary M791SBT1000HT0