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Scope Buddy Adapter

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name
SCOPE BUDDY ADAPTER FDA UDI
Generic Name
Luer/non-ISO80369-standardized linear connector, reusable FDA UDI
Device Name
SCOPE BUDDY ADAPTER FDA UDI
Model / Reference
SB-110-HU1005 FDA UDI
Description
SCOPE BUDDY ADAPTER FDA UDI

Identifiers

Catalog Number
SB110HU1005 FDA UDI
Primary DI / UDI-DI
00677964056246 FDA UDI
510(k) Number
K162128 FDA UDI
FDA Product Code
FEB FDA UDI
GMDN Term
Luer/non-ISO80369-standardized linear connector, reusable 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

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

Yes

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

Scope Buddy Adapter by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K162128 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medivators Inc.

Sources (1)

  • FDA UDI 1207bfc7-7093-4cc3-bc00-151fe6424b93 37 fields · synced May 30, 2026