FDA.report

Pilling

Primary DI
04026704531264
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN007845
Catalog number
506053
Device description
JESBERG FENEST GRASP FCPS 50CM
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
FATBougie, esophageal, and gastrointestinal, gastro-urology
GENFORCEPS, GENERAL & PLASTIC SURGERY
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications

CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1
KTIBronchoscope AccessoryEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704531264Direct MarkingGS10
44026704417085PackageGS120In Commercial Distribution
24026704417081PrimaryGS10
24026704531268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704531264040267045312644026704531264
4402670441708544026704417085
2402670441708124026704417081
2402670453126824026704531268

GMDN Terms

TermDefinition
ENT forcepsA general-purpose ear/nose/throat (ENT) surgical instrument designed to facilitate the grasping, holding, or manipulation of anatomical structures (e.g., trachea, ear) or devices (e.g., cochlear implant electrode array) during ENT procedures. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles with the working end having a variety of blade designs, e.g., straight, or curved with grooves or serrations to provide grip; and 2) a tweezers-like design (may be a micro/fine instrument) with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length50Centimeter
Length75Centimeter

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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