Celfina Cover Motor Module

GUDID 10848340010160

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use
Primary Device ID10848340010160
NIH Device Record Keyf408e7e9-0536-4872-8025-6f720f98703b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelfina Cover Motor Module
Version Model Number1005344
Company DUNS130785884
Company NameADVANCE MEDICAL DESIGNS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340010163 [Primary]
GS110848340010160 [Package]
Contains: 00848340010163
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

[10848340010160]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-18
Device Publish Date2024-04-10

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