FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660110208
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Mayo common duct scoop
Catalog number
44-901
Device description
Mayo common duct scoop, 11'', malleable, size #1, small
Published
2021-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHLSCOOP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660110208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660110208001906601102081906601102080190660110208

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use 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
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
00887482173695Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174708Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174715Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174777Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174784Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174791Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174807Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
00810158210158PRINCETONPrinceton Medical Group, Inc.FHL2024-03-05
G586UR96223150Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225100Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225170Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225180Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225190Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226120Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226130Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226140Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
00842331174582Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331174599Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331178900Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14