FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660092580
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Hardy knife handle
Catalog number
38-200
Device description
Hardy knife handle, 9 1/2'', bayonet shaft, working length 90mm, lateral, 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
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660092580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660092580001906600925801906600925800190660092580

GMDN Terms#

Term, Definition table
TermDefinition
Razor blade breaker/holderA surgical instrument specially designed to be used to break, breakable razor blades into shards of extremely sharp segments. Once this is done the instrument can then be used as a safety holder for the segment of broken razor blade, acting as a handle, whilst the surgeon uses it like a scalpel to cut tissue. When the operation is completed the segment of blade is disposed of. Some physicians prefer this method which guarantees the sharpness of the cutting edge. This device is made of high quality stainless-steel alloy and is designed like a short-nosed plier with a locking device to lock the blade segment securely in place. 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
00190776418038MillenniumAvalign Technologies, Inc.GDZ2026-03-23
16937372521523comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521530comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521547comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521554comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521561comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521578comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
B382SD4811280Surgical DirectSurgical Direct, Inc.GDZ2026-02-16
00190776416157MillenniumAvalign Technologies, Inc.GDZ2026-02-06
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
09348811000019INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000095INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000132INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000149INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000170INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000187INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000194INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000200INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000217INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000224INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014146INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014856INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014863INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811151452INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-01-22
00841013120480Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-06
00841013124327American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02
00841013124334American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02