FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613110673
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
TDK-4-319
Device description
"Needle Holder, Titanium, Straight, Delicate 7mm Jaws, With Lock, Round Handle, Overall Length 4-1/4"" (109mm)"
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613110673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613110673001946131106731946131106730194613110673

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(610)935-8181sales@msiprecision.com

Regulatory Flags#

DUNS number
556623486
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194613017279MSI Precision Specialty InstrumentsE53772025-08-01
00194613017286MSI Precision Specialty InstrumentsE53782025-08-01
00194613018993MSI Precision Specialty InstrumentsM134002025-08-01
00194613044572MSI Precision Specialty InstrumentsF94982025-08-01
00194613089696MSI Precision Specialty InstrumentsF94952025-08-01
00194613109684MSI Precision Specialty InstrumentsE53702025-08-01
00194613110772MSI Precision Specialty InstrumentsE53762025-08-01
00194613003845MSI Precision Specialty Instruments5-14452024-08-15
00194613044800MSI Precision Specialty Instruments17-13502024-08-15
00194613045173MSI Precision Specialty Instruments17-13302024-08-15
00194613045685MSI Precision Specialty Instruments2380182024-08-15
00194613046354MSI Precision Specialty Instruments17-13122024-08-15
00194613055332MSI Precision Specialty Instruments17-13102024-08-15
00194613018382MSI Precision Specialty Instruments52-20632025-08-01
00194613018504MSI Precision Specialty Instruments52-22612025-08-01
00194613018771MSI Precision Specialty Instruments51-23012025-08-01
00194613018788MSI Precision Specialty Instruments51-25012025-08-01
00194613018856MSI Precision Specialty Instruments51-19012025-08-01
00194613020873MSI Precision Specialty Instruments51-20012025-08-01
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058749121087NAFehling Instruments GmbH & Co. KGHCF2026-03-05
00198506088223ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-27
00198506088162ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506088179ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506087660ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00198506087776ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00848657077989AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00848657077996AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
10850012846519C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
04058749118711NAFehling Instruments GmbH & Co. KGHCF2025-12-08
00190776411916MillenniumAvalign Technologies, Inc.HCF2025-09-25
00840217909952Wiggins medicalEbner Medical, LLCHCF2025-09-17
00198506085581ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-12
00198506085024ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-05
00198506084812ELMED INCORPORATEDELMED INCORPORATEDHCF2025-08-26
G4533352105310PEAK MEDICALPeak Medical Distribution Inc.HCF2025-08-13
00194613009137MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009151MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009168MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009182MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009205MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009229MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009236MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009243MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009267MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009274MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613009298MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613039493MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613039516MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01
00194613051181MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01