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
OTC
false
Sterile
false
Single use
false

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810163790577Diamatrix Ltd.C6162026-05-26
00810163790546Diamatrix Ltd.N04350.8N04350.82026-03-24
00813059013491Dacrios Opthalmic KnivesD3705D37052026-03-19
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
00810163790300Diamatrix Ltd.C125-23C125-232025-05-22
00810163790362Inami & Co., Ltd.M-2220LM-2220L2025-05-20
00810163790379Inami & Co., Ltd.M-2220RM-2220R2025-05-20
00810163790270Diamatrix Ltd.H215-C-TH215-C-T2025-04-22
00810163790263Diamatrix Ltd.N04871N048712025-03-27
00810163790256Inami & Co., Ltd.DS-2022SDS-2022S2025-02-11
00810163790232Diamatrix Ltd.M75SM75S2025-01-27
00810163790249Diamatrix Ltd.C276-21.3C276-21.32025-01-27
00810163790195Diamatrix Ltd.S106-CSS106-CS2024-12-12
00810163790201Diamatrix Ltd.C154-21C154-212024-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
G04320061G0GEIZBear-Ent, LLCHNR2026-05-26
G04320062G0GEIZBear-Ent, LLCHNR2026-05-26
G04320065G0GEIZBear-Ent, LLCHNR2026-05-26
G04320067G0GEIZBear-Ent, LLCHNR2026-05-26
G04320068G0GEIZBear-Ent, LLCHNR2026-05-26
00041533986522Bruder KarpeckiThe Hilsinger Company Parent, LlcHNR2026-05-22
04251047910340Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047910357Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047911675Utrata Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047913990Kelman-McPherson Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
04251047918261Castroviejo Needle HolderA1 Medical GmbHHNR2026-05-22
04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047925399Ergo Grip Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047928383Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047931581Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047932250Micro Gripping ForcepsA1 Medical GmbHHNR2026-05-22
04251047932281ILM ForcepsA1 Medical GmbHHNR2026-05-22
04251047933165SIGNUM LEHNER MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933189SIGNUM INAMURA MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047934407Alio MICS Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047934711Gerten DMEK Rhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047936418Gerten Iridectomy ForcepsA1 Medical GmbHHNR2026-05-22
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23