FDA UDI In Commercial Distribution 🇺🇸 United States

TRAUS SIP10

DI: 08809260470163 · Model: TRAUS XIP10 · Saeshin Precision Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
TRAUS SIP10
Primary DI
08809260470163
Version / Model
TRAUS XIP10
Company Name
Saeshin Precision Co., Ltd.
Labeler DUNS
688019566
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-22
Public Version
1
Public Version Date
2020-01-30
Public Version Status
New
Public Device Record Key
bc81d5fc-0bd8-4be3-91c1-814fe7566c68

Device Description

Control Box 272.0(W) x 203.0(D) x 67.4(H)

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKY Handpiece, Water-Powered

GMDN Terms

Code Name
45572 Dental power tool system, line-powered

Identifiers

Type ID
Primary 08809260470163