FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660062897
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Malleus nipper forceps
Catalog number
31-780
Device description
Malleus nipper forceps, 4 1/2'', delicate, straight, 6.0mm jaws, 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
JYRNIPPER, MALLEUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYRNipper, MalleusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660062897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660062897001906600628971906600628970190660062897

GMDN Terms#

Term, Definition table
TermDefinition
Otologic clampA hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194613081287MSI Precision Specialty InstrumentsMed Saver, Inc.JYR2025-08-01
00810158213524PRINCETONPrinceton Medical Group, Inc.JYR2024-11-18
00810158212602PRINCETONPrinceton Medical Group, Inc.JYR2024-07-24
00810158212640PRINCETONPrinceton Medical Group, Inc.JYR2024-07-24
00840183527464BR Surgical, LLCBR Surgical, LLCJYR2024-07-19
00840183526955BR Surgical, LLCBR Surgical, LLCJYR2024-05-29
00810158212190PRINCETONPrinceton Medical Group, Inc.JYR2024-05-14
00840306822612Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822629Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822636Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822643Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822650Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822667Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822674Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822681Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822698Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822704Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00810158211636PRINCETONPrinceton Medical Group, Inc.JYR2024-03-26
00810158210738PRINCETONPrinceton Medical Group, Inc.JYR2024-03-08
00842962144633HNM MedicalHNM STAINLESS, LLC.JYR2024-03-08
00810158210202PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210257PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210271PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210400PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
G586E7212680Novo SurgicalNOVO SURGICAL, INC.JYR2023-12-18
G586E7218110Novo SurgicalNOVO SURGICAL, INC.JYR2023-12-18
00190776221119AvalignAvalign Technologies, Inc.JYR2023-09-28
00190776318505MILLENNIUMAvalign Technologies, Inc.JYR2023-09-28