FDA.report

ProTekt

Primary DI
00813059014283
Brand
ProTekt
Company
Diamatrix
Model
PG 44515SS
Device description
ProTekt Slit Knife, 2.4mm, Single Bevel Up, Angled
Published
2019-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HNNKnife, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813059014283PackageGS16In Commercial Distribution
00813059014306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059014283008130590142838130590142830813059014283
00813059014306008130590143068130590143060813059014306

GMDN Terms

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

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
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
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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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