| Primary Device ID | 00848657076975 |
| NIH Device Record Key | 308a0f94-ae6c-475e-b6b6-cccc29da05fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AED |
| Version Model Number | GT-STZ1592 NM |
| Company DUNS | 839138955 |
| Company Name | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00848657076975 [Primary] |
| NWV | Laparoscopic accessories, gynecologic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
[00848657076975]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-30 |
| Device Publish Date | 2024-07-22 |
| 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 |