FDA UDI In Commercial Distribution 🇺🇸 United States

WOODPECKER

DI: 06944843604282 · Model: Woodpex V · Guilin Woodpecker Medical Instrument Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
WOODPECKER
Primary DI
06944843604282
Version / Model
Woodpex V
Company Name
Guilin Woodpecker Medical Instrument Co., Ltd.
Labeler DUNS
545272577
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-25
Public Version
1
Public Version Date
2021-09-02
Public Version Status
New
Public Device Record Key
7fdfa1c4-dee9-411c-bae3-f7bce545339e

Device Description

Apex locator, endodontic

Device Characteristics

Single Use
No
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
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LQY Locator, Root Apex

GMDN Terms

Code Name
16355 Endodontic apex locator

Identifiers

Type ID
Primary 06944843604282

Premarket Submissions

Submission Number Supplement Number
K181087 000