FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC.

DI: 00840018661097 · Model: RPCWHO-11L · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC.
Primary DI
00840018661097
Version / Model
RPCWHO-11L
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-22
Public Version
2
Public Version Date
2023-01-20
Public Version Status
Update
Public Device Record Key
da7b59aa-d8bb-4c07-9719-cc8c7efe0833

Device Description

Hammacher Expro, DE, Probe WHO Ball Tip "PSR" (3.5-5.5-8.5-11.5 mm) - Explorer #11 Long

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
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
EKB Explorer, Operative

GMDN Terms

Code Name
35812 Dental surgical probe, reusable

Identifiers

Type ID
Primary 00840018661097