FDA.report

Disposable Instruments

Primary DI
10845819001384
Brand
Disposable Instruments
Company
OASIS MEDICAL, INC.
Model
6007
Device description
Lacrimal Cannula, 25g x 1-1/2”, Closed End, Curved
Published
2023-05-30
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

Contact Domains

Product Codes

CodeName
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845819001384PackageGS110In Commercial Distribution
00845819001387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900138410845819001384
00845819001387008458190013878458190013870845819001387

GMDN Terms

TermDefinition
Lacrimal procedural cannulaA hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
9093055400customerservice@oasismedical.com

Regulatory Flags

DUNS number
194121018
Device count
1
DM exempt
false
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

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00845819000267SOFT PLUG® Extended Duration Plugs 6400V2023-07-31
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10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
10845819000080SOFT PLUG® Silicone Punctum Plug6610-S, 6610, 6610-D2023-06-30
10845819000103SOFT PLUG® Silicone Punctum Plug6611-S, 6611, 6611-D2023-06-30
00845819000120SOFT PLUG® Silicone Punctum Plug6612-S, 6612, 6612-D2023-06-30
10845819000141SOFT PLUG® Silicone Punctum Plug6612-SFC, 6612-FC2023-06-30
10845819000172SOFT PLUG® Silicone Punctum Plug6613-S, 6613, 6613-D2023-06-30
10845819000202SOFT PLUG® Silicone Punctum Plug6614-S, 6614, 6614-D2023-06-30
10845819000226SOFT PLUG® Silicone Punctum Plug6614-SFC, 6614-FC2023-06-30
10845819000271FORM FIT® Hydrogel Canalicular Plug6303, 6303-T, B-63032023-06-30
10845819000318Lacrimal lntubation Set60042023-06-30

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