Ambler Surgical

Primary DI
00190660109691
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Shambaugh-Derlacki mobilizer
Catalog number
43-110
Device description
Shambaugh-Derlacki mobilizer, 6 1/4'', straight shaft, angled, serrated tip, flat 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
KAJMOBILIZER, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAJMobilizer, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660109691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660109691001906601096911906601096910190660109691

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. 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
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
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770406791Bausch + LombBausch & Lomb IncorporatedKAJ2026-02-11
00757770406838Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00757770436231Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00840183527495BR Surgical, LLCBR Surgical, LLCKAJ2024-11-26
00887482042472Symmetry HoughASPEN SURGICAL PRODUCTS, INC.KAJ2024-08-20
00190776044602AvalignAvalign Technologies, Inc.KAJ2023-09-28
00190776320263MillenniumAvalign Technologies, Inc.KAJ2023-06-23
14026704805522PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
54026704805520PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
00842331165078Novo Surgical Inc. NOVO SURGICAL, INC.KAJ2022-11-13
10381780082439Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAJ2018-10-24
10885403010026V. MuellerSTERIS CORPORATIONKAJ2018-07-13
10885403009778V. MuellerSTERIS CORPORATIONKAJ2018-07-13