Anastomosis Leak Tester-LP ALT-50

GUDID 00861838000361

Expedite and standardize the 'bubble test' for colorectal anastomoses.

TOOLS FOR SURGERY, LLC

Endoscope inflation bulb
Primary Device ID00861838000361
NIH Device Record Key3f9cd4eb-dd9f-4714-9906-048cc7a896d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnastomosis Leak Tester-LP
Version Model NumberALT-50
Catalog NumberALT-50
Company DUNS841842441
Company NameTOOLS FOR SURGERY, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com
Phone6314444448
Emailinfo@toolsforsurgery.com

Device Dimensions

Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch
Length8.7 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100861838000361 [Primary]

FDA Product Code

FCYBulb, Inflation, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-04
Device Publish Date2019-09-26

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