FDA UDI In Commercial Distribution 🇺🇸 United States

BLT External Implant(SLA)

DI: 08809486112717 · Model: BLERS4108 · EBI Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BLT External Implant(SLA)
Primary DI
08809486112717
Version / Model
BLERS4108
Company Name
EBI Inc.
Labeler DUNS
689515003
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-22
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
05025bd2-a14e-43bf-8bd6-625c34898230

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
55848 Screw endosteal dental implant, one-piece

Identifiers

Type ID
Primary 08809486112717