Benesta Fluid Pack

GUDID 00857492008089

Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals.

Caldera Medical, Inc.

Surgical suction system Y-piece valve-connector
Primary Device ID00857492008089
NIH Device Record Keyb19b09e0-674e-4987-a063-172ea51f5991
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenesta Fluid Pack
Version Model NumberCAL-1411
Company DUNS130341956
Company NameCaldera Medical, 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 Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a clean, dry location

Device Identifiers

Device Issuing AgencyDevice ID
GS100857492008089 [Package]
Contains: 00857492008119
Package: Box [5 Units]
In Commercial Distribution
GS100857492008119 [Primary]

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-26
Device Publish Date2022-07-18

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