EndoTBasket ET2035

GUDID 10816207020041

Endoscopic retrieval device, large elliptical basket

ENDO-THERAPEUTICS, INC.

Gastrointestinal/airway foreign body retrieval basket
Primary Device ID10816207020041
NIH Device Record Key2b8ecefa-0725-4bc4-9f0f-7095c7d83c01
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTBasket
Version Model NumberET2035
Catalog NumberET2035
Company DUNS825239189
Company NameENDO-THERAPEUTICS, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com

Device Dimensions

Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length220 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100816207020044 [Primary]
GS110816207020041 [Package]
Contains: 00816207020044
Package: box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [EndoTBasket]

10816207020126Endoscopic retrieval device, medium hexagonal basket
10816207020119Endoscopic retrieval device, large hexagonal basket
10816207020096Endoscopic retrieval device, medium hexagonal basket
10816207020089Endoscopic retrieval device, large hexagonal basket
10816207020072Endoscopic retrieval device, large hexagonal basket
10816207020065Endoscopic retrieval device, medium hexagonal basket
10816207020058Endoscopic retrieval device, medium elliptical basket
10816207020041Endoscopic retrieval device, large elliptical basket
10816207020034Endoscopic retrieval device, medium elliptical basket
10816207020027Endoscopic retrieval device, large elliptical basket
10816207020010Endoscopic retrieval device, medium elliptical basket
10816207020003Endoscopic retrieval device, large elliptical basket
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