FDA.report

Pinnacle X-Ray Sensor Sheath

Primary DI
D683PSS31001
Brand
Pinnacle X-Ray Sensor Sheath
Company
METREX RESEARCH, LLC
Model
PSS3100C
Device description
Fits DEXIS Platinum CustomFitted for Your Sensor UltraSoft Material Soft Seams
Published
2017-02-15
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
00615375004777PrimaryGS10
D683PSS31001SecondaryHIBCC0
00615375007532Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615375004777006153750047776153750047770615375004777
00615375007532006153750075326153750075320615375007532

GMDN Terms

TermDefinition
Cable/lead/sensor/probe cover, non-sterileA non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18008411428customercare@kavokerrgroup.com

Regulatory Flags

DUNS number
145963778
Device count
100
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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