FDA.reportPublic FDA data

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

Primary DI
04719878789530
Brand
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
Company
Paonan Biotech Co.,Ltd.
Model
420-0013
Catalog number
420-0013
Device description
L-Cage NEST Instrument Tray
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878789530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878789530047198787895304719878789530

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
04710281445792“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0104NSC-01042026-05-11
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376778372InvictusALPHATEC SPINE, INC.FSM2026-08-19
00190376778396InvictusALPHATEC SPINE, INC.FSM2026-08-19
08800322759516Torque Limiting HandleGS Medical Co., Ltd.FSM2026-08-18
10806378116810ACUMEDAcumed LLCFSM2026-08-18
10806378116827ACUMEDAcumed LLCFSM2026-08-18
10806378116841ACUMEDAcumed LLCFSM2026-08-18
10806378116858ACUMEDAcumed LLCFSM2026-08-18
G8791062750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072790DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072800DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107280S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC05S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC07S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC21N0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
03700879517803airlock®NOVASTEPFSM2026-08-17