FDA.reportPublic FDA data

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

Primary DI
04710281445792
Brand
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
Company
Paonan Biotech Co.,Ltd.
Model
NSC-0104
Catalog number
NSC-0104
Device description
NEST-C Slotted Hammer
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710281445792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710281445792047102814457924710281445792

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
657397790
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710281445723“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0200NSC-02002026-05-11
04719878789400“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0100NSC-01002026-05-11
04719878789417“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0101NSC-01012026-05-11
04719878789424“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0102NSC-01022026-05-11
04719878789431“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0103NSC-01032026-05-11
04719878789455“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0001NSC-00012026-05-11
04719878789462“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0002NSC-00022026-05-11
04719878789509“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0010420-00102026-05-11
04719878789530“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0013420-00132026-05-11
04719878789653“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2405NSC-24052026-05-11
04719878789660“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2406NSC-24062026-05-11
04719878789677“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2407NSC-24072026-05-11
04719878789684“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2408NSC-24082026-05-11
04719878789691“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2409NSC-24092026-05-11
04719878789707“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2605NSC-26052026-05-11
04719878789714“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2606NSC-26062026-05-11
04719878789721“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2607NSC-26072026-05-11
04719878789738“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2608NSC-26082026-05-11
04719878789745“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2609NSC-26092026-05-11
04719899787973“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0011C420-0011C2026-05-11

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