FDA.report

Pilling

Primary DI
04026704517466
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN005418
Catalog number
351755
Device description
BLANCO VALVE SPREADER
Published
2018-09-15
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704517466Direct MarkingGS10
24026704517460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704517466040267045174664026704517466
2402670451746024026704517460

GMDN Terms

TermDefinition
Cardiac retractorA hand-held manual surgical instrument designed to separate or draw aside the edges of an incision in the heart, various anatomical structures of the heart (e.g., an atrium or aortic valve), or the entire organ. It consists of a handle proximally and a wire frame-like blade, with no sharp edges, that can have various shapes and angles at the distal tip. It is made of high-grade stainless steel and may have a synthetic material for the handle (e.g., Tufnol). This is a reusable device.

Device Sizes

TypeValueUnit
Length29Centimeter
Width9Millimeter

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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