FDA.reportPublic FDA data

Pilling

Primary DI
04026704530595
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN007772
Catalog number
505050
Device description
CIRCULAR CUP BIOPSY 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEKFORCEPS, BIOPSY, BRONCHOSCOPE (RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEKForceps, Biopsy, Bronchoscope (Rigid)Ear, 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
04026704530595Direct MarkingGS10
24026704530599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704530595040267045305954026704530595
2402670453059924026704530599

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
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
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
24026704530643PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704530667PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704530698PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704530957PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704530971PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704531022PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
04026704530649PillingTELEFLEX INCORPORATEDJEK2018-09-15
04026704530663PillingTELEFLEX INCORPORATEDJEK2018-09-15
04026704530694PillingTELEFLEX INCORPORATEDJEK2018-09-15
04026704530953PillingTELEFLEX INCORPORATEDJEK2018-09-15
04026704530977PillingTELEFLEX INCORPORATEDJEK2018-09-15
04026704531028PillingTELEFLEX INCORPORATEDJEK2018-09-15
24026704532821PILLINGTELEFLEX INCORPORATEDJEK2018-09-15
24026704530575PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530582PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530599PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530605PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530612PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530629PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530636PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530650PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530674PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530681PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530704PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530711PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530735PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530773PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530780PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530797PILLINGTELEFLEX INCORPORATEDJEK2016-09-16
24026704530810PILLINGTELEFLEX INCORPORATEDJEK2016-09-16