FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660110048
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Goldman bone saw
Catalog number
44-800
Device description
Goldman bone saw, 7 1/2'', bayonet shaft, angled right, 27.0mm blade, 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDRSAW, MANUAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660110048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660110048001906601100481906601100480190660110048

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw blade, rigidA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a rigid manual hand saw used for cutting bone/tissue when a directional pressure is applied. This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is manually powered in a back and forth motion by the user. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08403207009517Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
08403207009579Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
04049047061984GimmiGimmi GmbHGDR2025-05-20
04049047062080GimmiGimmi GmbHGDR2025-05-20
00810123208593Adler Instrument CompanyAdler, Inc.GDR2025-02-12
04049197537292RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-10-16
04049197499248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499262RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197149983RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197149990RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150002RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150125RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150163RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205146RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205153RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
00190776385774MillenniumAvalign Technologies, Inc.GDR2024-05-09
00842517107533Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00842517107540Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00888515192003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192010BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192027BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192034BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192058BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192065BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192072BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192089BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192096BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515201927BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515201965BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28