FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660100742
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Bone mallet replacement nylon head
Catalog number
41-146
Device description
Bone mallet replacement nylon head, 25.0mm diameter
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
GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660100742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660100742001906601007421906601007420190660100742

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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
true
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
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00810207783268Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFJ2025-11-24
00810207783275Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFJ2025-11-24
00810207783282Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFJ2025-11-24
00190776407094MillenniumAvalign Technologies, Inc.GFJ2025-09-12
00190776409883MillenniumAvalign Technologies, Inc.GFJ2025-09-08
00190776407674MillenniumAvalign Technologies, Inc.GFJ2025-08-01
00190776402907MillenniumAvalign Technologies, Inc.GFJ2025-06-30
00190776401795MillenniumAvalign Technologies, Inc.GFJ2025-06-13
08056992093058MalletMC BIO SRLGFJ2025-06-06
00190776400064MillenniumAvalign Technologies, Inc.GFJ2025-06-04
00190776397562MillenniumAvalign Technologies, Inc.GFJ2025-05-16
00840314269744gSourceGSOURCE LLCGFJ2025-05-05
B7687710420Buxton BioMedicalBuxton Biomedical IncGFJ2025-03-27
00850073363270SI-RESTOREBIOFUSION MANAGEMENT AND MANUFACTURING, LLCGFJ2025-03-17
00810130205790MSIModern Surgical Instruments LLCGFJ2025-03-12
00810123208661Adler Instrument CompanyAdler, Inc.GFJ2025-03-04
08403207008275Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008282Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
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08403207008336Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008343Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008350Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008367Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
00841336111523Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGFJ2024-12-11
00840343725204GEN2SURGIX MEDICAL LLCGFJ2024-12-04
00889813064344Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGFJ2024-11-30