FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660108762
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Deschamps ligature carrier
Catalog number
44-446
Device description
Deschamps ligature carrier, 8 1/2'', for left hand, sharp, 3.5mm, flat 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
GEJCARRIER, LIGATURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660108762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660108762001906601087621906601087620190660108762

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. 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
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613063443MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482041451Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054918Symmetry SurgicalSYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054925Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00854037007170eXact Suture Placement DeviceCypris Medical, Inc.GEJ2024-06-10
00190776382711MillenniumAvalign Technologies, Inc.GEJ2024-05-06
00888515204522BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204539BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204591BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204607BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
G586UR6208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
G586UR96208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
00190776262549AvalignAvalign Technologies, Inc.GEJ2023-09-28
00840319750018Hayden MedicalHayden Medical, Inc.GEJ2023-03-21
00854037007149eXact 5.1Cypris Medical, Inc.GEJ2023-02-28
54026704788748PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
54026704811026PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
10885403133237V. MuellerCAREFUSION 2200, INCGEJ2022-11-27
00840306808111Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-21
00840306808142Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-14
00840306808319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-10
00840306808104Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808128Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808135Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840343713454GEN2SURGIX MEDICAL LLCGEJ2022-11-04
00840343713461GEN2SURGIX MEDICAL LLCGEJ2022-11-04