FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660107635
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Salyer nasal lining dissector
Catalog number
44-290
Device description
Salyer nasal lining dissector, 7'', right angled, 7.0mm wide 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
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660107635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660107635001906601076351906601076350190660107635

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122895Ball DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122901Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122918Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122925Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122932Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
09348811151254INKAThe Trustee for KAISER FAMILY TRUSTGDI2026-03-16
00192896122703Ochsner DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-10
00840180544778General InstrumentsALPHATEC SPINE, INC.GDI2026-01-29
00840180544525General InstrumentsALPHATEC SPINE, INC.GDI2025-12-31
08809407604543DissectorHankil Tech Medical Co., Ltd.GDI2025-12-16
00196449034536Anatomic Access LLIFTyber Medical, LLCGDI2025-12-02
09348811025494INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811025500INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811146663INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
03662663276849Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-17
00757770701209Bausch + LombBausch & Lomb IncorporatedGDI2025-11-16
03662663267236Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267243Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267250Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
00757770676354Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
00757770688517Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
03662663131308Disc Preparation InstrumentsHighridge Medical, LLCGDI2025-11-14
03662663192835Breckenridge ACDF SystemHighridge Medical, LLCGDI2025-11-14
00196449034529Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00763000936440NAMEDTRONIC, INC.GDI2025-09-29
00192896122116Ball ProbeSONTEC INSTRUMENTS, INC.GDI2025-09-26
16971503601937comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
16971503601944comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28