Hexagonal Basket - Large BGH-1315L

GUDID 10816207020454

Endoscopic retrieval device, large hexagonal basket

ENDO-THERAPEUTICS, INC.

Gastrointestinal/airway foreign body retrieval basket Gastrointestinal/airway foreign body retrieval basket Gastrointestinal/airway foreign body retrieval basket Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use
Primary Device ID10816207020454
NIH Device Record Keyb8b403a5-aade-46e2-8615-562fe34bec17
Commercial Distribution Discontinuation2019-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHexagonal Basket - Large
Version Model NumberBGH-1315L
Catalog NumberBGH-1315L
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

Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length150 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
GS100816207020457 [Primary]
GS110816207020454 [Package]
Contains: 00816207020457
Package: box [10 Units]
Discontinued: 2019-11-04
Not 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 Number4
Public Version Date2019-11-05
Device Publish Date2016-09-20

Devices Manufactured by ENDO-THERAPEUTICS, INC.

10816207021178 - 4 Chamber Polyp Trap2023-07-19 Suction system canister, 4 chambers, fixed
10816207021253 - AcuJect Flex2023-07-19 Endoscopic injection needle
10816207021321 - RotoNet2023-07-19 Endoscopic Retrieval Net - Mini
10816207021338 - RotoNet2023-07-19 Endoscopic Retrieval Net - Standard, Esophageal
10816207021345 - RotoNet2023-07-19 Endoscopic Retrieval Net - Standard, Colonic
10816207021352 - RotoNet2023-07-19 Endoscopic Retrieval Net - Standard, Enteroscope
10816207021369 - RotoNet2023-07-19 Endoscopic Retrieval Net - Maxi, Esophageal
10816207021376 - RotoNet2023-07-19 Endoscopic Retrieval Net - Maxi, Colonic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.