FDA.report

Pinnacle Headrest Cover

Primary DI
D68335111
Brand
Pinnacle Headrest Cover
Company
METREX RESEARCH, LLC
Model
3511C
Device description
Patient Chair Headrest Sleeves
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MMPCover, barrier, protective

Product Code Classifications

CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615375004500PrimaryGS10
D68335111SecondaryHIBCC0
00615375007303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615375004500006153750045006153750045000615375004500
00615375007303006153750073036153750073030615375007303

GMDN Terms

TermDefinition
Headrest coverA non-sterile device designed as an outer covering and used for the protection of a headrest against unhygienic conditions and helps prevent the occurrence of gross soiling. It will typically be made of thin, shaped, plastic/textile material which creates a physical barrier between the patient's head and the head supporting device. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18008411428customercare@kavokerrgroup.com

Regulatory Flags

DUNS number
145963778
Device count
250
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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