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Elliptical Basket, Medium

FDA UDI

Class II (US FDA UDI)

by Endo-Therapeutics, Inc.

Identity

Trade Name
Elliptical Basket, Medium FDA UDI
Generic Name
Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
Device Name
Endoscopic retrieval device, medium basket FDA UDI
Model / Reference
BGE-1315M FDA UDI
Description
Endoscopic retrieval device, medium basket FDA UDI

Identifiers

Catalog Number
BGE-1315M FDA UDI
Primary DI / UDI-DI
00816207020402 FDA UDI
510(k) Number
K800970 FDA UDI
FDA Product Code
OCZ FDA UDI
GMDN Term
Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.7 Millimeter FDA UDI
Length — 150 Centimeter FDA UDI

Elliptical Basket, Medium by Endo-Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K800970 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endo-Therapeutics, Inc.

Sources (1)

  • FDA UDI 8f0b1dcc-c63c-4629-9bfa-abf9c30b6c35 39 fields · synced Jun 8, 2026