FDA.reportPublic FDA data

Pilling

Primary DI
00190776024550
Brand
Pilling
Company
AVALIGN TECHNOLOGIES, INC.
Model
P18777
Device description
Myocardial Dilator
Published
2017-03-23
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
DWPDILATOR, VESSEL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776024550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776024550001907760245501907760245500190776024550

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.75Inch
Width2Millimeter
Width17.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159035926SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWP2025-11-13
00887482160893Symmetry Surgical®SYMMETRY SURGICAL INC.DWP2024-08-14
00190776387617MillenniumAvalign Technologies, Inc.DWP2024-05-10
00190776387624MillenniumAvalign Technologies, Inc.DWP2024-05-10
00190776387631MillenniumAvalign Technologies, Inc.DWP2024-05-10
00190776387648MillenniumAvalign Technologies, Inc.DWP2024-05-10
04058749118773NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749118827NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749118834NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749118841NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749118858NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119015NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119022NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119039NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119046NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119121NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119138NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749119145NAFehling Instruments GmbH & Co. KGDWP2024-04-09
04058749118803NAFehling Instruments GmbH & Co. KGDWP2024-03-27
04058749119190NAFehling Instruments GmbH & Co. KGDWP2024-03-27
04058749119213NAFehling Instruments GmbH & Co. KGDWP2024-03-27
04058749119237NAFehling Instruments GmbH & Co. KGDWP2024-03-27
04058749119244NAFehling Instruments GmbH & Co. KGDWP2024-03-27
00810123206582Adler Instrument CompanyAdler, Inc.DWP2023-12-14
04058749118810NAFehling Instruments GmbH & Co. KGDWP2023-12-08
04058749119183NAFehling Instruments GmbH & Co. KGDWP2023-12-08
04058749119206NAFehling Instruments GmbH & Co. KGDWP2023-12-08
04058749118957NAFehling Instruments GmbH & Co. KGDWP2023-12-06
04058749119053NAFehling Instruments GmbH & Co. KGDWP2023-12-06
04058749119114NAFehling Instruments GmbH & Co. KGDWP2023-12-06