FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660197711
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Needle blade
Catalog number
5910
Device description
Needle blade, 3.0mm wide, straight blade, screw-in, flat stock, packaged individually, sterile, disposable, box of 6
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
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
00190660197711PackageGS16In Commercial Distribution
10190660197718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660197711001906601977111906601977110190660197711
1019066019771810190660197718

GMDN Terms#

Term, Definition table
TermDefinition
Tympanotomy knife, single-useA sterile, 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 typically 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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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
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04054462906598evonosevonos GmbH & Co. KGJYO2026-08-21
04054462900282evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
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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
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00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
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