AED

GUDID 00848657066396

Hystero Diagnostic Sheath

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope sheath, reusable

• Primary Device ID: 00848657066396
• NIH Device Record Key: ce962536-58e4-43be-a0f3-edd90df9fff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED
• Version Model Number: HS2305
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657066396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141515

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00848657066396]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-11-30

On-Brand Devices [AED]

• 00848657086363: Tishler-Morgan GYN Forceps, 20cm
• 00848657086356: Tishler-Morgan GYN Forceps, 20cm
• 00848657086349: Tishler-Baby GYN Forceps, 25cm
• 00848657086332: Tishler-Baby GYN Forceps, 20cm
• 00848657086325: AED Kevorkian-Pacific GYN Forceps, 20cm
• 00848657086318: AED Burke GYN Forceps, 20cm
• 00848657086301: AED Micro HD Ureteroscope
• 00848657086295: AED TRU-VU Laser Resectoscope System
• 00848657085953: Tru Vu Operating Hysteroscope, 8.5mm x 18FR
• 00848657085946: Tru Vu Operating Hysteroscope, 6.3mm x 12FR
• 00848657085939: Tru Vu Operating Hysteroscope, 5.8mm x 11FR
• 00848657085922: Tru Vu Operating Hysteroscope, 6.5mm x 9FR
• 00848657085915: Tru Vu Mini Palpation Probe, 5FR, 40cm
• 00848657085908: Tru Vu Mini Trocar/Cannula, 2mm, 9.5cm
• 00848657085892: Tru Vu Mini Button Electrode, 5FR, 40cm
• 00848657085885: Tru Vu Mini Trocar/Cannula, 3.5mm, 20cm
• 00848657085878: Tru Vu Mini Trocar/Cannula, 3.5mm, 15cm
• 00848657085861: AED Sinuscope 2.7mm x 70 degree, 100mm
• 00848657085854: AED Sinuscope 2.7mm x 70 degree, 170mm
• 00848657085762: AED ENDOPRO-CAM®Portable HD Endoscope Video System
• 00848657085755: Tru Vu Mini Operative Laparoscope, 3.5mm x 30cm, 5FR Channel
• 00848657085304: AED Brow Lift Retractor Set
• 00848657085298: AED Brow Lift Retractor
• 00848657084925: 1mm Cup Forcep, D/A, 35cm WL
• 00848657084918: ESS-WA22367A Bipolar Working Element
• 00848657084901: 4mm Diameter Mushroom Punch #521.26
• 00848657084895: 5mm Sinus Backbiter 2.5mm Cut #525.13
• 00848657084888: Pointed Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
• 00848657084871: Hook Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
• 00848657084864: Smooth Fenestrated Mini-Op Lap Grasper, Semi-Rigid, 5FR
• 00848657084857: Blunt Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
• 00848657084840: Biopsy Mini-Op Lap Grasper, Semi-Rigid, 5FR
• 00848657084833: Alligator Fenestrated Mini-Op Lap Grasper, Semi-Rigid, 5FR
• 00848657084352: AED Kerrison 2mm Cervical Custom
• 00848657083584: AED Kerrison, 1mm x 200mm
• 00848657066945: AED Composite Axial Handle Needle Holder, 45cm, Curved Right Jaw with T/C Inserts
• 00848657066938: Composite Axial Handle Needle Holder, 36cm, Curved Right Jaw with T/C Inserts
• 00848657066921: AED Composite Axial Handle Needle Holder, 45cm, Curved Left Jaw with T/C Inserts
• 00848657066914: AED Composite Axial Handle Needle Holder, 45cm, Straight Jaw with T/C Inserts
• 00848657066891: AED Axial Handle Needle Holder, Curved Right Jaw with T/C Inserts
• 00848657066884: AED Axial Handle Needle Holder, Curved Left Jaw with T/C Inserts
• 00848657066877: AED Axial Handle Needle Holder, Straight Jaw with T/C Inserts
• 00848657066860: Laparoscopic Flexible Retractor Triangle Shape
• 00848657066853: Laparoscopic Flexible Retractor Large D Shape
• 00848657066846: Laparoscopic Spatula with Irrigation, 5mm X 45cm
• 00848657066839: Laparoscopic Spatula with Irrigation, 5mm X 33cm
• 00848657066822: Laparoscopic J-Hook, 5mm X 45cm
• 00848657066815: Laparoscopic J-Hook, 5mm X 33cm
• 00848657066808: Laparoscopic L-Hook, 5mm X 45cm
• 00848657066792: Laparoscopic L-Hook, 5mm X 33cm