FDA.report

Diamatrix

Primary DI
00813059017697
Brand
Diamatrix
Company
Diamatrix
Model
DCP04
Catalog number
DCP04
Device description
DACRIOS 0.4mm X 2mm Collagen (Temporary) Punctal Plug, Box of 10
Published
2021-07-12
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
false

Related Records

Contact Domains

Product Codes

CodeName
LZUPlug, Punctum

Product Code Classifications

CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813059017697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059017697008130590176978130590176970813059017697

GMDN Terms

TermDefinition
Lacrimal punctum plugA sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
2813678081cs@diamatrix.com

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

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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
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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
00385640089562Summit MedicalSummit Medical, Inc.LZU2025-12-29
00385640089579Summit MedicalSummit Medical, Inc.LZU2025-12-29
10840277405095Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405101Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405118Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405125Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
08800024300009Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300016Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300672Hello, eyesBio Optics Co., LtdLZU2024-07-30
00810061911944SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911951SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911968SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911975SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911982SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911913SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911920SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911937SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
23700773734768TearSaver® - 0.4 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734775TearSaver® - 0.5 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734782TearSaver® - 0.6 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734799TearSaver® - 0.7 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734805TearSaver® - 0.8 mmFCI S A S FCI 20 22LZU2023-11-13
00850048647206Quintess Tear PoolEl Paso Medical, LLCLZU2023-08-11
00850048647213Quintess Tear PoolEl Paso Medical, LLCLZU2023-08-11
00845819000267SOFT PLUG® Extended Duration Plugs OASIS MEDICAL, INC.LZU2023-07-31
10845819000219SOFT PLUG® Extended Duration Plugs OASIS MEDICAL, INC.LZU2023-07-31
10845819005481SOFT PLUG® Extended Duration PlugsOASIS MEDICAL, INC.LZU2023-07-31
10845819000080SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30
10845819000103SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30
00845819000120SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30