57810A AED 8mm x 0 Degree x 17cm Endoscope 57810A

GUDID 00848657069458

An endoscope with a rigid inserted portion intended to be used in plastic surgery for reconstructive operations, the suction of subcutaneous tissue, or vein harvesting.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Rigid reconstructive surgery endoscope

Primary Device ID	00848657069458
NIH Device Record Key	5c0740b2-e10c-494b-9d6b-915a4cda87e8
Commercial Distribution Status	In Commercial Distribution
Brand Name	57810A AED 8mm x 0 Degree x 17cm Endoscope
Version Model Number	57810A
Catalog Number	57810A
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	false
Manufacturing Date	true
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

Customer Support Contacts

Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md
Phone	(818) 227-2720
Email	customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657069458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K993688

FDA Product Code

GCJ	Laparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

[00848657069458]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-10-17
Device Publish Date	2023-10-09

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

00848657076975 - AED	2024-07-30 AED Titanium Pistol Handle Needle Holder, 38cm, Straight Jaw; Non-Magnetic Version
00848657076982 - AED	2024-07-30 Non-Magnetic Johan Bowel Grasper 5mm x 36cm
00848657076999 - AED	2024-07-30 Non-Magnetic Maryland Grasper 5mm x 36cm, Serrated
00848657077002 - AED	2024-07-30 Non-Magnetic Metzenbaum 5mm x 36cm, Curved
00848657077019 - AED	2024-07-30 Precise Lap Bulldog Clamp with diamond dust anti-skid coating, 60mm, Non-Magnetic Version
00848657077026 - AED	2024-07-30 Precise Lap Bulldog Clamp Forcep, 12.5mm x 38cm, Non-Magnetic Version
00848657076968 - ENDOPRO-CAM Master Series	2024-07-23 Endoscopic Video System
00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm	2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm

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