FDA.reportPublic FDA data

ExactEtch

Primary DI
00813059017338
Brand
ExactEtch
Company
Diamatrix
Model
2115NS
Catalog number
2115NS
Device description
ExactEtch Stab Knife, 30 Degree, Straight, Non-Sterile
Published
2021-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HNNKnife, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059017338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059017338008130590173388130590173380813059017338

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. 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
true
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
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
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00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675053MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675060MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675077MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675183MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675190MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675206MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675220MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16