FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660029494
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Bakes common bile duct dilators
Catalog number
43-909
Device description
Bakes common bile duct dilators, 9'', 9.0mm
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
FFPDILATOR, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660029494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660029494001906600294941906600294940190660029494

GMDN Terms#

Term, Definition table
TermDefinition
Urethral bougie, reusableA rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. 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
Premarket exempt
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850005838487Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
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00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
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