Ambler Surgical

Primary DI
00190660031107
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
McCrea female sound
Catalog number
44-905
Device description
McCrea female sound, 7 5/8'', curved, 8 French
Published
2021-01-04
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
FBSSOUND, METAL, INTERCONNECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBSSound, Metal, InterconnectedGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660031107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660031107001906600311071906600311070190660031107

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
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
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
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776294588AvalignAvalign Technologies, Inc.FBS2023-11-15
00190776248475AvalignAvalign Technologies, Inc.FBS2023-11-13
00190776329594MILLENNIUMAvalign Technologies, Inc.FBS2023-09-28
00190776378035MILLENNIUMAvalign Technologies, Inc.FBS2023-09-28
00190776163785MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163792MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163808MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163815MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163822MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163839MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163846MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163853MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163860MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190776163877MillenniumAVALIGN TECHNOLOGIES, INC.FBS2021-11-01
00190660030964Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660030971Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660030988Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660030995Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031008Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031015Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031022Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031039Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031046Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031053Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031060Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031077Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031084Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04
00190660031091Ambler SurgicalAMBLER SURGICAL CORP.FBS2021-01-04