FDA.report

Pinnacle Cure Sleeve

Primary DI
D68345111
Brand
Pinnacle Cure Sleeve
Company
METREX RESEARCH, LLC
Model
4511C
Device description
Curing Light Tip Sleeves Fits 11mm Tips
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
00615375004647PrimaryGS10
D68345111SecondaryHIBCC0
00615375007440Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615375004647006153750046476153750046470615375004647
00615375007440006153750074406153750074400615375007440

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
400
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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