FDA UDI In Commercial Distribution 🇺🇸 United States

OKTAGON BL NC Healing abutment, Ø 5.5 mm GH 5.0 mm

DI: EDRS220721 · Model: 22072 · Hager & Meisinger Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
OKTAGON BL NC Healing abutment, Ø 5.5 mm GH 5.0 mm
Primary DI
EDRS220721
Version / Model
22072
Catalog Number
22072
Company Name
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Labeler DUNS
318034329
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-15
Public Version
2
Public Version Date
2019-02-14
Public Version Status
Update
Public Device Record Key
4cdae731-a9e3-4806-bef8-b7d7dfbc7448

Device Description

BL NC Healing abutment, Ø 5.5 mm GH 5.0 mm for OKTAGON Dental Implant BL NC

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
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
55849 Screw endosteal dental implant, two-piece

Identifiers

Type ID
Primary EDRS220721
Previous EDRS220729

Customer Contacts