FDA.report

PILLING

Primary DI
34026704639848
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN002488
Catalog number
087420
Device description
MAT SILICONE SPIKED 11" X 20"
Published
2019-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704639848Direct MarkingGS10
14026704639844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670463984834026704639848
1402670463984414026704639844

GMDN Terms

TermDefinition
Instrument tray linerA non-sterile, durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp surgical instruments and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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