Foot Switch Drape

GUDID 10848340006071

Foot Switch Drape

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use
Primary Device ID10848340006071
NIH Device Record Keye13462f8-a353-4a5d-acd1-f783c6f2b67b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot Switch Drape
Version Model NumberFS1515NS
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340006074 [Primary]
GS110848340006071 [Package]
Contains: 00848340006074
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 Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-11
Device Publish Date2022-11-03

Devices Manufactured by ADVANCE MEDICAL DESIGNS, INC.

10848340010481 - Mitaka Drape2024-04-25 Disposable Equipment Cover
10848340011464 - Mitaka Spy Elite2024-04-25 Disposable Equipment Cover
10848340015530 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340016834 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340016858 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340015547 - Rolled Probe Cover2024-04-23 Disposable Equipment Cover
10848340012089 - Sterile Elastic Bands2024-04-22 Sterile Elastic Bands
10848340015486 - C-Arm Pack2024-04-22 Disposable Equipment Cover

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.