PediaBloc Endoscopy Bite Block GIS-2-S

GUDID 10893029002530

Endoscopy Bite Block

GI Supply, Inc.

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Primary Device ID10893029002530
NIH Device Record Key59479bcc-a547-4814-9821-8a0a1387df76
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediaBloc Endoscopy Bite Block
Version Model NumberGIS-2
Catalog NumberGIS-2-S
Company DUNS160990313
Company NameGI Supply, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com
Phone800-451-5797
Emailinfo@gi-supply.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100893029002533 [Primary]
GS110893029002530 [Package]
Contains: 00893029002533
Package: Master [100 Units]
In Commercial Distribution
GS120893029002537 [Package]
Contains: 00893029002533
Package: Dispenser [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNKEndoscopic Bite Block

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-15
Device Publish Date2021-07-07

Devices Manufactured by GI Supply, Inc.

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10893029002165 - RenovaRP Tube Set2022-08-18 RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remov
10893029002592 - MoonPants SM2021-07-28 MoonPants SM single-use non-sterile garment
10893029002608 - MoonPants ML2021-07-28 MoonPants ML single-use non-sterile garment
10893029002615 - MoonPants XL2021-07-28 MoonPants XL single-use non-sterile garment
10893029002622 - MoonPants Long2021-07-28 MoonPants Long single-use non-sterile garment
00893029002670 - SportShorts XS2021-07-28 SportShorts XS single-use non-sterile garment
00893029002687 - SportShorts SM2021-07-28 SportShorts SM single-use non-sterile garment
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