Ambler Surgical

Primary DI
00190660029968
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
44-470
Catalog number
44-470
Device description
"Garrett vascular dilator set, 8 1/4"", holder only"
Published
2016-09-29
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
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
00190660029968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660029968001906600299681906600299680190660029968

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

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
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
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

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00887482160893Symmetry GarrettASPEN SURGICAL PRODUCTS, INC.DWP2024-08-14
04058749118780NAFehling Instruments GmbH & Co. KGDWP2024-01-08
04058749118797NAFehling Instruments GmbH & Co. KGDWP2024-01-08
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34026704652670PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652687PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
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00192896010703GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-29
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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
00192896005570GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21
00192896005587GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21