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AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed

FDA UDI

Class II (US FDA UDI)

by Alpha-Omega Services, Inc.

Identity

Trade Name
AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed FDA UDI
Generic Name
Neck brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adaptor, Cable Insert, with Green Nylon Retaining Buttons and Stainless Steel Retaining Buttons, 20 ea FDA UDI
Model / Reference
TIB0001-003 FDA UDI
Description
Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adaptor, Cable Insert, with Green Nylon Retaining Buttons and Stainless Steel Retaining Buttons, 20 ea FDA UDI

Identifiers

Primary DI / UDI-DI
00850645007137 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
Neck brachytherapy system applicator, remote-afterloading FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed by Alpha-Omega Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alpha-Omega Services, Inc.

Sources (1)

  • FDA UDI fd36ec78-45ad-42fb-a7a8-42736aa1ad90 34 fields · synced Jun 8, 2026