FDA.reportPublic FDA data

ASSI

Primary DI
00841645130833
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATK36426
Device description
Cottle Mallet, 18 cm, 300gms 1flat face for use w/chisels, 1 round face for use with bone crusher
Published
2020-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00841645130833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645130833008416451308338416451308330841645130833

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

Regulatory Flags#

DUNS number
055870299
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
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71200TBS BASICSACME ENTERPRISE.GFJ2026-05-22
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
08403207008299Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008305Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008312Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
08403207008329Anmuth Medical InternationalAnmuth Medical International, LLCGFJ2025-01-24
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