FDA.reportPublic FDA data

Ambler Surgical

Primary DI
10190660197954
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Tympanoplasty blade
Catalog number
7210
Device description
Tympanoplasty blade, straight, 2.5mm wide, screw-in, flat stock, packaged individually, sterile, disposable, box of 6
Published
2021-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660197957PackageGS16In Commercial Distribution
10190660197954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660197957001906601979571906601979570190660197957
1019066019795410190660197954

GMDN Terms#

Term, Definition table
TermDefinition
Tympanotomy knife, single-useA hand-held, manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
04054462901937evonosevonos GmbH & Co. KGJYO2026-08-21
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04054462906406evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906413evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906420evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906437evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906444evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906451evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906468evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906475evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906536evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906543evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906581evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906598evonosevonos GmbH & Co. KGJYO2026-08-21
04054462900282evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901920evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901951evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901968evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906482evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906499evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906550evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906567evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906574evonosevonos GmbH & Co. KGJYO2026-08-18
04054462907533evonosevonos GmbH & Co. KGJYO2026-08-18
09348811109194INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811150257INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811109798INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-30
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11