FDA.report

TELEFLEX

Primary DI
14026704666901
Brand
TELEFLEX
Company
TELEFLEX INCORPORATED
Model
IPN055296
Catalog number
70010
Device description
Remover-Universal - 11
Published
2020-01-08
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
FZPCLIP, IMPLANTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704666901Direct MarkingGS10
24026704666908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1402670466690114026704666901
2402670466690824026704666908

GMDN Terms

TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

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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