FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660211950
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Hiebert vascular dilator
Catalog number
44-584
Device description
Hiebert vascular dilator, 6'', double-ended, size 3.5mm/4.0mm, round handle
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWPDILATOR, VESSEL, SURGICAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100518000INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.2010-08-31DWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660211950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660211950001906602119501906602119500190660211950

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400347MillenniumAvalign Technologies, Inc.DWP2026-07-17
B382SD9081971000Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971010Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971020Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971030Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971040Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382S8711000Surgical DirectSurgical Direct, Inc.DWP2026-07-14
B382S8711010Surgical DirectSurgical Direct, Inc.DWP2026-07-14
B382S8711020Surgical DirectSurgical Direct, Inc.DWP2026-07-14
00192896123359Sarns Myocardial DilatorSONTEC INSTRUMENTS, INC.DWP2026-04-23
14026704927873PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927880PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927897PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927903PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
04058749118780NAFehling Instruments GmbH & Co. KGDWP2024-01-08
34026704652618PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652625PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652632PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652649PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652656PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652670PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652687PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704655961PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652663PILLINGTELEFLEX INCORPORATEDDWP2020-03-23
00192896010703GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-29
00192896005563GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010680GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010697GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010710TUNNELERSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010727TUBBS MITRAL VALVE DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24