AED

GUDID 00848657066396

Hystero Diagnostic Sheath

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope sheath, reusable
Primary Device ID00848657066396
NIH Device Record Keyce962536-58e4-43be-a0f3-edd90df9fff8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED
Version Model NumberHS2305
Company DUNS839138955
Company NameNATIONAL ADVANCED ENDOSCOPY DEVICES, 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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848657066396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848657066396]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2017-11-30

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00848657084888Pointed Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
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00848657066945AED Composite Axial Handle Needle Holder, 45cm, Curved Right Jaw with T/C Inserts
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00848657066921AED Composite Axial Handle Needle Holder, 45cm, Curved Left Jaw with T/C Inserts
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00848657066891AED Axial Handle Needle Holder, Curved Right Jaw with T/C Inserts
00848657066884AED Axial Handle Needle Holder, Curved Left Jaw with T/C Inserts
00848657066877AED Axial Handle Needle Holder, Straight Jaw with T/C Inserts
00848657066860Laparoscopic Flexible Retractor Triangle Shape
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00848657066846Laparoscopic Spatula with Irrigation, 5mm X 45cm
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00848657066822Laparoscopic J-Hook, 5mm X 45cm
00848657066815Laparoscopic J-Hook, 5mm X 33cm
00848657066808Laparoscopic L-Hook, 5mm X 45cm
00848657066792Laparoscopic L-Hook, 5mm X 33cm

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