Icon Surgical MDIC5454150

GUDID 16975424194561

Microscope drape

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID	16975424194561
NIH Device Record Key	0a069228-3a62-480a-889a-8a8411ac02fc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Icon Surgical
Version Model Number	MDIC5454150
Catalog Number	MDIC5454150
Company DUNS	014464314
Company Name	EXACT MEDICAL MANUFACTURING, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424194564 [Primary]
GS1	16975424194561 [Package] Contains: 06975424194564 Package: Inner Case [10 Units] In Commercial Distribution
GS1	26975424194568 [Package] Package: Case [1 Units] In Commercial Distribution

FDA Product Code

KKX	Drape, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-08
Device Publish Date	2023-10-31

On-Brand Devices [Icon Surgical]

00850003355573	Microscope drape
16975424194561	Microscope drape