FDA.reportPublic FDA data

PILLING

Primary DI
24026704530926
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN007809
Catalog number
505342
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04026704530922Direct MarkingGS10
24026704530926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704530922040267045309224026704530922
2402670453092624026704530926

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28.2Centimeter

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

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