FDA UDI Not in Commercial Distribution 🇺🇸 United States

Body Pro-Lok ONE™ System

DI: 00841439102343 · Model: BPL110 · MEDTEC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Body Pro-Lok ONE™ System
Primary DI
00841439102343
Version / Model
BPL110
Catalog Number
BPL110
Company Name
MEDTEC, INC.
Labeler DUNS
103977526
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-02
Public Version
6
Public Version Date
2019-05-23
Public Version Status
Update
Public Device Record Key
1aa28f99-db7d-4c64-b6e0-7ec8f922948d
Distribution End Date
2019-03-20

Device Description

Bpl One Bridge System, Multi

Device Characteristics

Single Use
No
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
Yes
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

Product Codes

Code Name
LNH System, nuclear magnetic resonance imaging
IYE Accelerator, linear, medical

GMDN Terms

Code Name
40902 Radiological whole-body positioner

Identifiers

Type ID
Primary 00841439102343

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K111340 000

Device Sizes

Type Value Unit Text
Length 72 Inch
Width 24.1 Inch