FDA.report

PILLING

Primary DI
04026704522798
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN006007
Catalog number
355301
Device description
DEBAKEY DILATOR 5MM 19CM
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DWPDILATOR, VESSEL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704522798Direct MarkingGS10
24026704522792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704522798040267045227984026704522798
2402670452279224026704522792

GMDN Terms

TermDefinition
Artery clampA hand-held manual surgical instrument designed for the temporary, atraumatic compression of an artery for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and designs of the working end are specific to the surgical application. This is a reusable device.

Device Sizes

TypeValueUnit
Length7.5Inch
Outer Diameter5Millimeter

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
true
Sterilization required before use
true

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