FDA.reportPublic FDA data

GoldenDent

Primary DI
00850011211090
Brand
GoldenDent
Company
GoldenDent
Model
FS NCS
Catalog number
FS NCS
Device description
Needle Holder 7 inch Advanced with Round handle with suture cutter and straight tips
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011211090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011211090008500112110908500112110900850011211090

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078273228
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
00850028211335WagotrixWGWL-100WGWL-1002021-02-25
00850028211342WagotrixWGWM-100WGWM-1002021-02-25
00850028211359WagotrixWGWS-100WGWS-1002021-02-25
00850011211625GoldenDentGMXRGMXR2021-02-25
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211830GoldenDentGO CGCGO CGC2021-02-25
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211823GoldenDentGO BFIGO BFI2021-02-25
00850011211915GoldenDentGO SPCGO SPC2021-02-25
00850011211403GoldenDentGK06GK062021-02-25
00850011211410GoldenDentGK08GK082021-02-25
00850011211427GoldenDentGK10GK102021-02-25
00850011211434GoldenDentGK15GK152021-02-25
00850011211441GoldenDentGK20GK202021-02-25
00850011211458GoldenDentGK25GK252021-02-25
00850011211465GoldenDentGK30GK302021-02-25
00850011211472GoldenDentGK35GK352021-02-25
00850011211489GoldenDentGK40GK402021-02-25
00850011211496GoldenDentGK45GK452021-02-25
00850011211502GoldenDentGK50GK502021-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432577MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432744MillenniumAvalign Technologies, Inc.GEN2026-09-28
00724995268985Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995268992Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269005Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269012Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269029Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269036Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269043Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
B35665124160American MedicalsAmerican MedicalsGEN2026-09-25
00724995266752Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-24
00190776431273MillenniumAvalign Technologies, Inc.GEN2026-09-22