FDA.reportPublic FDA data

Pilling

Primary DI
04026704530946
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN007811
Catalog number
505402
Device description
JACKSON GRASPING FCPS 35CM
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)
KTRTUBE, ASPIRATING, BRONCHOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEKForceps, Biopsy, Bronchoscope (Rigid)Ear, Nose, Throat2
KTRTube, Aspirating, Bronchoscope, RigidEar, 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
04026704530946Direct MarkingGS10
24026704399882PrimaryGS10
24026704530940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704530946040267045309464026704530946
2402670439988224026704399882
2402670453094024026704530940

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
Length35Centimeter
Length417Millimeter

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
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704919984PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704919991PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920003PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920010PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920027PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920034PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920058PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920065PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920072PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920096PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920102PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920119PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920133PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920140PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920157PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920164PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920171PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920188PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920195PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920201PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920218PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920225PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920232PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920256PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920515PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704919982PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704919999PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920001PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920018PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920025PILLINGTELEFLEX INCORPORATEDKTR2024-07-15