FDA.report

Pilling

Primary DI
04026704509409
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN003521
Catalog number
164412
Device description
RETR VOLKMAN RAKE 2 PRONG BLUNT 8-5/8"
Published
2016-09-16
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
false

Related Records

Contact Domains

Product Codes

CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704509409Direct MarkingGS10
24026704509403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704509409040267045094094026704509409
2402670450940324026704509403

GMDN Terms

TermDefinition
Abdominal retractor, hand-heldA surgical instrument designed to be held by the surgeon or assistant to separate the margins of an abdominal incision, typically during deep surgery, to expose or access organs or tissues for examination or intervention. The instrument consists of a blunt-edged, non-adjustable flat blade that curves near the distal tip, with a solid handle at the proximal end. The surgeon or assistant uses this instrument to manually pull the edge of the incision open. It is made of high-grade stainless steel and is available in a variety of blade lengths. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length21.5Centimeter
Width0.375Inch

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
false
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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