FDA.reportPublic FDA data

Mathieu Hole Tip

Primary DI
08961104621954
Brand
Mathieu Hole Tip
Company
MELPEX BEAUTY INSTRUMENTS
Model
Single Spring
Catalog number
15-008S
Device description
Mathieu Hole Tip Single Spring
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08961104621954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08961104621954089611046219548961104621954

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
645674404
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08961104621824Mathieu Standard TipDouble Spring15-006D2026-05-21
08961104621831Mathieu Standard TipSingle Spring15-006S2026-05-21
08961104621848Mathieu Standard Tip TCDouble Spring15-006DTC2026-05-21
08961104621855Mathieu Standard Tip TCSingle Spring15-006STC2026-05-21
08961104621862Mathieu Narrow TipDouble Spring15-002D2026-05-21
08961104621879Mathieu Narrow TipSingle Spring15-002S2026-05-21
08961104621886Mathieu Narrow Tip TCDouble Spring15-002DTC2026-05-21
08961104621893Mathieu Narrow Tip TCSingle Spring15-002STC2026-05-21
08961104621909Mathieu Narrow Tip HalfDouble Spring15-016D2026-05-21
08961104621916Mathieu Narrow Tip HalfSingle Spring15-016S2026-05-21
08961104621923Mathieu Hook TipDouble Spring15-014D2026-05-21
08961104621930Mathieu Hook TipSingle Spring15-014S2026-05-21
08961104621947Mathieu Hole TipDouble Spring15-008D2026-05-21
08961104621961Mathieu Hook Tip GroovedDouble Spring15-014GD2026-05-21
08961104621978Mathieu Hook Tip GroovedSingle Spring15-014GS2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipSingle Spring20-020S 2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipDouble Spring20-020D2026-05-21
08961104622142Strip PlacerStrip Placer16-261A2026-05-21
08961104622159polar bear Martensitic positionerMartensitic positioner16-2612026-05-21
08961104622166Positive PositionerPositive Positioner16-2602026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434892MillenniumAvalign Technologies, Inc.FHQ2026-10-14
B382SD9055891010Surgical DirectSurgical Direct, Inc.FHQ2026-10-13
00810220800621Adler Instrument CompanyAdler, Inc.FHQ2026-10-07
00192896123816Jacobson Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-10-06
B382SD905582180Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
B382SD9056791090Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
B382SD9056791170Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
G141521149260Carnegie Surgical LLCCarnegie Surgical LLCFHQ2026-09-30
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28