FDA.report

Halyard

Primary DI
30680651446405
Brand
Halyard
Company
Avanos Medical, Inc.
Model
44640
Catalog number
44640
Device description
Cardiovascular Split Drape
Published
2017-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
30680651446405PackageGS14Not in Commercial Distribution
10680651446401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065144640530680651446405
1068065144640110680651446401

GMDN Terms

TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags

DUNS number
079375431
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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