FDA.reportPublic FDA data

Diamatrix

Primary DI
00813059015495
Brand
Diamatrix
Company
Diamatrix
Model
N10-S
Device description
Barraquer Needle Holder, Fine Delicate, Straight shaft, 10mm smooth jaws with pointed tips, Without Lock, Diamond knurled handle, 135mm total length, Stainless
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059015495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059015495008130590154958130590154950813059015495

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
809555139
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810163790577Diamatrix Ltd.C6162026-05-26
00810163790553Diamatrix Ltd.G151G1512026-04-29
00813059013354Dacrios Opthalmic KnivesD3210D32102026-04-14
00810163790546Diamatrix Ltd.N04350.8N04350.82026-03-24
00813059013491Dacrios Opthalmic KnivesD3705D37052026-03-19
00810163790430Diamatrix Ltd.F003F0032025-10-21
00810163790447Diamatrix Ltd.H805-1.5H805-1.52025-10-21
00810163790454Diamatrix Ltd.H805-3H805-32025-10-21
00810163790461Diamatrix Ltd.F300S.5F300S.52025-10-21
00810163790478Inami & Co., Ltd.S-325S-3252025-10-20
00810163790423Diamatrix Ltd.C223A-25C223A-252025-10-07
00810163790416Diamatrix Ltd.F775S2025-08-06
00810163790386Diamatrix Ltd.C119-21C119-212025-06-30
00810163790393Diamatrix Ltd. H188FH188F2025-06-30
00810163790409Diamatrix Ltd.C027-8C027-82025-06-30
00810163790348Diamatrix Ltd.F002F0022025-06-13
00810163790317Diamatrix Ltd.H854H8542025-06-06
00810163790324Diamatrix Ltd.IT-.5-CIT-.5-C2025-06-06
00810163790331Diamatrix Ltd.F445S.5F445S.52025-05-27
00810163790355Diamatrix Ltd.F040-1.2F040-1.22025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055251544Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810055251551Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
00810212931654SURGIPROSSurgipros, LLCFHQ2026-06-01
00810055250721Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250752Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250783Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250790Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250806Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250813Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250820Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250844Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250851Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250882Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250905Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250912Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450028Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450035Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450066Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450073Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450080Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450103Surgical DesignSurgical Design, Inc.FHQ2026-05-29
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D5052200TENNAT TYING FORCEPS STR DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052300TENNAT TYING FORCEPS CVD DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052340MAUMENEE TYING FORCEPS STRDAUD JEE MFG. COHNR2023-01-05
G006D5052350MAUMENEE TYING FORCEPS ANGDAUD JEE MFG. COHNR2023-01-05