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AED 85910B Endo Breast Scope, 10mm x 17.5cm, 30 Degree

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
AED 85910B Endo Breast Scope, 10mm x 17.5cm, 30 Degree FDA UDI
Generic Name
Rigid optical reconstructive surgery endoscope FDA UDI
Device Name
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. FDA UDI
Model / Reference
85910B FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
85910B FDA UDI
Primary DI / UDI-DI
00848657074896 FDA UDI
510(k) Number
K993688 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Rigid optical reconstructive surgery endoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical reconstructive surgery endoscope

AED 85910B Endo Breast Scope, 10mm x 17.5cm, 30 Degree by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Rigid optical reconstructive surgery endoscope.

Cleared under the same submission

K993688 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Advanced Endoscopy Devices, Inc.

Sources (1)

  • FDA UDI 48d5e947-13b3-40bd-a924-7c0bc70ce6bc 36 fields · synced May 30, 2026