FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660160722
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Gorney facelift (Rhytidectomy) scissors
Catalog number
77-820
Device description
Gorney facelift (Rhytidectomy) scissors, 8'', straight TC blades, semi-sharp edges, micro serrated lower blade, blunt tips, gold ring handle
Published
2021-01-07
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
KBDSCISSORS, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBDScissors, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660160722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660160722001906601607221906601607220190660160722

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

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
09348811114723INKAThe Trustee for KAISER FAMILY TRUSTKBD2025-12-01
09348811115157INKAThe Trustee for KAISER FAMILY TRUSTKBD2025-12-01
00810207780533Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780540Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780557Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780564Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780571Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780588Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780595Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780625Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780632Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780649Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780656Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780663Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780670Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780687Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780694Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781035Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781042Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781264Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781271Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781288Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781295Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781530Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781547Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781554Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207781561Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-24
00810207780618Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKBD2025-11-14
04250381818213ScissorsSpiggle & Theis Medizintechnik GmbHKBD2025-09-08
04250381819524Metzenbaum scissorsSpiggle & Theis Medizintechnik GmbHKBD2025-09-08