FDA.reportPublic FDA data

PILLING

Primary DI
04026704518906
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN005581
Catalog number
352691
Device description
BUSH VALVULOTOME 95 CENTIMETER 2 MILLIMETER HEAD
Published
2018-09-15
Public version status
New
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704518906Direct MarkingGS10
24026704518900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704518906040267045189064026704518906
2402670451890024026704518900

GMDN Terms#

Term, Definition table
TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length37.375Inch

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
true
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
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389989DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219390220DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510062DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510086DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219511687DELACROIX-CHEVALIERLANDANGERDWS2026-07-04
03661219141440DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219143499DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266204DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266358DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266969DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
00884450376171One-Tie®Merit Medical Systems, Inc.DWS2026-06-06
00810220800324Adler Instrument CompanyAdler, Inc.DWS2026-06-02
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00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28