Patient Drape/ Clear View Drape

GUDID 10848340010498

Disposable Waste Fluid Collection Device

ADVANCE MEDICAL DESIGNS, INC.

Patient surgical drape, single-use
Primary Device ID10848340010498
NIH Device Record Key3437d175-f247-4b03-a5d5-bbf5362ae8d3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Drape/ Clear View Drape
Version Model NumberO-CVD-A1
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340010491 [Primary]
GS110848340010498 [Package]
Contains: 00848340010491
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


[10848340010498]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-17
Device Publish Date2022-05-09

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.