Impla Clean- Number 2

GUDID 00014081552228

Implant Cleaning Instrument

HAGER WORLDWIDE, INC.

Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable
Primary Device ID00014081552228
NIH Device Record Key6ff9d15d-c4e4-4508-9f6c-e23869fa4031
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpla Clean- Number 2
Version Model Number355222
Company DUNS009277971
Company NameHAGER WORLDWIDE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100014081552228 [Primary]

FDA Product Code

EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


[00014081552228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-22
Device Publish Date2023-03-14

Devices Manufactured by HAGER WORLDWIDE, INC.

D2483553190 - Plast Frame2024-04-24 Rubber dam frame
D248222300 - SafeDispense - Silver2024-04-22 Floss Holder/dispenser
D248222310 - Mini SafeDispense2024-04-22 Floss Holder/dispenser
D248222360 - SafeDispense - White2024-04-22 Floss Holder/dispenser
D248222380 - SafeDispense - Dual2024-04-22 Floss Holder/dispenser
D2486054500 - Mirahold Adult2024-02-13 Dental Cheek/Lip Retractor
D2484522210 - MetaLIFT Replacement Handle2023-12-15 MetaLIFT Crown and Bridge Remover replacement handle
D2484522220 - MetaLIFT Regular Removal Instrument Replacement Part2023-12-15 MetaLIFT Crown and Bridge Regular Remover replacement

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.