FDA.reportPublic FDA data

PILLING

Primary DI
04026704204960
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008472
Catalog number
522300P
Device description
CARLENS MEDIASTINUM SCOPE SHORT
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWYMEDIASTINOSCOPE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWYMediastinoscope, SurgicalEar, 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
04026704204960Direct MarkingGS10
24026704204964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704204960040267042049604026704204960
2402670420496424026704204964

GMDN Terms#

Term, Definition table
TermDefinition
Artery clampA hand-held manual surgical instrument designed for the temporary, atraumatic compression of an artery for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and designs of the working end are specific to the surgical application. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length116Millimeter
Outer Diameter18.4Millimeter

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
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
04048551425718NAKarl Storz GmbH & Co. KGEWY2025-03-27
24026704715293PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715309PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715316PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715323PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715330PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
00863189000311Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00863189000304Aegis Illuminated Mediastinal Access PortAEGIS SURGICAL LIMITEDEWY2017-03-14
10863189000318Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00814334021644NARichard Wolf GmbHEWY2016-09-30
04055207001097NARichard Wolf GmbHEWY2016-09-26
04055207009284NARichard Wolf GmbHEWY2016-09-26
04055207014806NARichard Wolf GmbHEWY2016-09-26
04055207020623NARichard Wolf GmbHEWY2016-09-26
04048551049587n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049594n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049570n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225387n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225424n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551242889DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04048551322062DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04055207000014NARichard Wolf GmbHEWY2016-09-23
04055207009260NARichard Wolf GmbHEWY2016-09-23
04055207020616NARichard Wolf GmbHEWY2016-09-23
04055207020630NARichard Wolf GmbHEWY2016-09-23
04055207020647NARichard Wolf GmbHEWY2016-09-23
04055207034071NARichard Wolf GmbHEWY2016-09-23
04055207034088NARichard Wolf GmbHEWY2016-09-23
04055207034095NARichard Wolf GmbHEWY2016-09-23
04055207034101NARichard Wolf GmbHEWY2016-09-23