FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660008536
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Alexander mastoid chisels
Catalog number
16-111
Device description
Alexander mastoid chisels, 7'', straight, 6.0mm wide edge, square 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYDCHISEL, MASTOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYDChisel, MastoidGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660008536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660008536001906600085361906600085360190660008536

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048266149190PediatrOS™ FlexTack™/ RigidTack™Merete GmbHJYD2021-11-01
00190660008499Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008505Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008512Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008529Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008543Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008604Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008611Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008628Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008635Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008642Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008659Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
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