FDA.reportPublic FDA data

Pacific Instruments

Primary DI
00850005084013
Brand
Pacific Instruments
Company
PACIFIC INSTRUMENTS, INC.
Model
PI-3016
Catalog number
PI-3016
Device description
Hajek Mallet
Published
2020-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850005084013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005084013008500050840138500050840130850005084013

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
621872006
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810168190457NAPI-34152026-05-26
00810168190310NAPI-39042026-05-11
00810168190327NAPI-39052026-05-11
00810168190334NAPI-39062026-05-11
00810168190341NAPI-39072026-05-11
00810168190358NAPI-39082026-05-11
00810168190365NAPI-39092026-05-11
00810168190372NAPI-39102026-05-11
00810168190389NAPI-39112026-05-11
00810168190402NAPI-39132026-05-11
00810168190419NAPI-39142026-05-11
00810168190426NAPI-36152026-05-11
00810168190433NAPI-39162026-05-11
00810168190440NAPI-39172026-05-11
00810168190303NAPI-12192026-03-16
00810168190297NAPI-38752026-03-03
00810168190167NAPI-38422026-01-29
00850005084334NAPI-34342023-09-01
00850005084693NAPI-25822024-03-28
00850005084082NAPI-33782024-03-18

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
00841732131743GENERIC Surgical InstrumentsCTL Medical CorporationHXL2025-02-24
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