FDA.report

Pilling

Primary DI
04026704451333
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN005430
Catalog number
351783
Device description
LEMOLE ATRIAL RETRACTOR
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
04026704451333Direct MarkingGS10
24026704451337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704451333040267044513334026704451333
2402670445133724026704451337

GMDN Terms

TermDefinition
Vessel retractorA hand-held, surgical instrument used for separating/drawing aside vascular structures to permit examination or intervention during a surgical procedure. It is typically a shaft-like instrument with an inwardly curved, saddle hook at the distal end and a handle at the proximal end. It may also be known as a vein retractor. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length26.5Centimeter
Width1.875Inch

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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