FDA.reportPublic FDA data

gSource

Primary DI
M7555978780
Brand
gSource
Company
GSOURCE LLC
Model
gS 59.7878
Catalog number
gS 59.7878
Device description
Repercussion Free Mallet 10 1/2", 1lb 5oz [595g], head s/s w/one nylon cap Ø 30mm, plastic hdl, black l
Published
2020-02-14
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
HXLMallet

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7555978780PrimaryHIBCC0

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
008162518
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
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00348783010213Premier MalletsPREMIER DENTAL PRODUCTS COMPANYGFJ2026-04-28
00190776418861MillenniumAvalign Technologies, Inc.GFJ2026-04-09
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00841731135322Redemption VILEX LLCHXL2026-01-12
00810074308748250mm MalletOsteocentric Technologies, Inc.HXL2025-10-21
00190776399023MillenniumAvalign Technologies, Inc.GFJ2025-05-27
00810130204762MSIModern Surgical Instruments LLCGFJ2024-12-10
00810158212732PRINCETONPrinceton Medical Group, Inc.HXL2024-09-05
10653160996415Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.HXL2024-07-29
00840314269553gSourceGSOURCE LLCGFJ2024-04-09
00840314269560gSourceGSOURCE LLCGFJ2024-04-09
00840314269522gSourceGSOURCE LLCGFJ2024-04-08
00840314269539gSourceGSOURCE LLCGFJ2024-04-08
00840314269546gSourceGSOURCE LLCGFJ2024-04-08
G586NS46317910Novo SurgicalNOVO SURGICAL, INC.GFJ2024-02-22
14026704722324KMEDICTELEFLEX INCORPORATEDHXL2023-10-13
14026704722331KMEDICTELEFLEX INCORPORATEDHXL2023-10-13
00840314269485gSourceGSOURCE LLCGFJ2023-10-10
00841732162754GENERIC Surgical InstrumentsCTL Medical CorporationHXL2023-09-27
B4192710710MSIModern Surgical Instruments LLCGFJ2023-01-27
M6335001000JEDMEDJEDMED INSTRUMENT COMPANYGFJ2022-12-20
M6335001400JEDMEDJEDMED INSTRUMENT COMPANYGFJ2022-12-20
B7682459190Buxton BioMedicalBuxton Biomedical IncGFJ2022-12-19
07898506847563QuinelatoSchobell Industrial LtdaGFJ2022-12-16
07898506813490QuinelatoSchobell Industrial LtdaGFJ2022-12-08
14026704807304PILLINGTELEFLEX INCORPORATEDGFJ2022-12-08
14026704807311PILLINGTELEFLEX INCORPORATEDGFJ2022-12-08
14026704807328PILLINGTELEFLEX INCORPORATEDGFJ2022-12-08
14026704807335PILLINGTELEFLEX INCORPORATEDGFJ2022-12-08