KOIS KR-1 PACKER

GUDID 00310866002552

RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD

PASCAL COMPANY, INC.

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Primary Device ID00310866002552
NIH Device Record Key91e1438b-6854-4a3d-b59c-788fc3d0674a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOIS KR-1 PACKER
Version Model Number26225
Company DUNS009260217
Company NamePASCAL COMPANY, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100310866002552 [Primary]

FDA Product Code

EIFAccessories, Retractor, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


[00310866002552]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-12
Device Publish Date2024-06-04

Devices Manufactured by PASCAL COMPANY, INC.

00310866002552 - KOIS KR-1 PACKER2024-06-12RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD
00310866002552 - KOIS KR-1 PACKER2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD
00310866002606 - KOIS KR-2 PACKER2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 1MM HEAD
00310866002613 - KOIS KR-3 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 1.5MM HEAD
00310866002620 - KOIS KR-4 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD
00310866002637 - KOIS KR-5 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2.5MM HEAD
00310866002644 - GET SCULPTED2024-05-24 Wax Carving Set
00310866002651 - Fluorilaq Salted Caramel (10mL) Tube2024-04-05 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments.
00310866002668 - Fluorilaq Mint (10mL) Tube2024-04-05 5% Fluoride Varnish with Xylitol. Ideal for cavity varnish.

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