FDA.report

Radial Drape w/ Oval Fenestration

Primary DI
20886333206685
Brand
Radial Drape w/ Oval Fenestration
Company
ARGON MEDICAL DEVICES, INC.
Model
CP01037A
Catalog number
CP01037A
Device description
Radial Drape w/ Oval Fenestration
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886333206685PackageGS125In Commercial Distribution
00886333206681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320668520886333206685
00886333206681008863332066818863332066810886333206681

GMDN Terms

TermDefinition
Angiographic drapeA flexible, protective covering made of natural or synthetic materials, or both, designed to be used on patients during an angiographic procedure to control microbial and substance (e.g., blood, contrast material) contamination of the patient entry field. It may be specific for brachial or femoral procedures, and may include a window(s) for viewing and/or a trough to collect spilled substances. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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