FDA UDI In Commercial Distribution 🇺🇸 United States

Removal Tool

DI: 08800011260545 · Model: ORTM · POINTIMPLANT Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Removal Tool
Primary DI
08800011260545
Version / Model
ORTM
Company Name
POINTIMPLANT Co., Ltd.
Labeler DUNS
695333960
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-02-21
Public Version
2
Public Version Date
2023-11-16
Public Version Status
Update
Public Device Record Key
2150ffa8-f5c3-44cd-b5b0-aadc6621b247

Device Characteristics

Single Use
No
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
Yes
Has Expiration Date
No
Has Donation ID
Yes

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
45714 Fixture/appliance dental drill bit, reusable

Identifiers

Type ID
Primary 08800011260545