FDA.reportPublic FDA data

Pilling

Primary DI
04026704530816
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN007856
Catalog number
506155
Device description
TUCKER BEAD FCPS SMALL 40CM
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEKFORCEPS, BIOPSY, BRONCHOSCOPE (RIGID)
KAEFORCEPS, ENT
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEKForceps, Biopsy, Bronchoscope (Rigid)Ear, Nose, Throat2
KAEForceps, EntEar, Nose, Throat1
KTIBronchoscope AccessoryEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990561000OPTICAL FORCEPSPilling Weck Surgical1999-05-14JEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704530816Direct MarkingGS10
24026704530810PrimaryGS10
24026704531343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704530816040267045308164026704530816
2402670453081024026704530810
2402670453134324026704531343

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter
Length50Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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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10801902180268ARROWIPN917220AI-071212021-08-19
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Primary DI, Brand, Company table
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04054462910847evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910854evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910861evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910878evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910885evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910892evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910908evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910991evonosevonos GmbH & Co. KGKAE2026-08-19
00190776417055MillenniumAvalign Technologies, Inc.KAE2026-08-18
00190776426484MillenniumAvalign Technologies, Inc.KAE2026-08-18
00810220800546Adler Instrument CompanyAdler, Inc.KAE2026-08-18
00810220800553Adler Instrument CompanyAdler, Inc.KAE2026-08-18
04054462900398evonosevonos GmbH & Co. KGKAE2026-08-18
04054462901777evonosevonos GmbH & Co. KGKAE2026-08-18
04054462901784evonosevonos GmbH & Co. KGKAE2026-08-18
04054462901791evonosevonos GmbH & Co. KGKAE2026-08-18
04054462903214evonosevonos GmbH & Co. KGKAE2026-08-18
04054462903221evonosevonos GmbH & Co. KGKAE2026-08-18
04054462903238evonosevonos GmbH & Co. KGKAE2026-08-18
04054462903245evonosevonos GmbH & Co. KGKAE2026-08-18
04054462913954evonosevonos GmbH & Co. KGKAE2026-08-18
04054462919239evonosevonos GmbH & Co. KGKAE2026-08-14
00190776423568MillenniumAvalign Technologies, Inc.KAE2026-08-07
00190776408671MillenniumAvalign Technologies, Inc.KAE2026-08-03
00190776422486MillenniumAvalign Technologies, Inc.KAE2026-07-31
00810143907834SURGIPROSSurgipros, LLCKAE2026-07-31