FDA.reportPublic FDA data

Garg

Primary DI
D943G54020
Brand
Garg
Company
Power Dental U.S.A. Inc.
Model
G5402
Catalog number
G5402
Device description
NEEDLE HOLDER CRILE-MURRAY 15cm
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMDHemostat, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943G54020PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)286-1635info@medequipdental.com

Regulatory Flags#

DUNS number
081305064
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7410TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7420TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7430TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7440TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7450TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7460TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7470TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7480TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7490TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149NP380760NPSACME ENTERPRISE.EMD2026-05-01
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
08800075610102OSUNG MNDOSUNG MND Co., Ltd.EMD2025-11-03
00841336101630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00841336101647Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
D928140052DLC0HEMOSTAT JACKSON, SLIGHT CURVED, DLC, 19 CMW.H. Holden, Inc.EMD2025-06-24
00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726379GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726386GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726393GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
00842517111417Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517111424Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112216Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
D928140051190HEMOSTAT CRAFOORD SLIGHT CURVED 19CMW.H. Holden, Inc.EMD2024-12-18
00840343725099GEN2SURGIX MEDICAL LLCEMD2024-11-07
00840343724702GEN2SURGIX MEDICAL LLCEMD2024-10-25
00840343724061GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343724078GEN2SURGIX MEDICAL LLCEMD2024-10-01