FDA.report

Disposable Instruments

Primary DI
10845819006099
Brand
Disposable Instruments
Company
OASIS MEDICAL, INC.
Model
4003-IK
Device description
Lacrimal Irrigation Kit, 3-mL Disposable Syringe and a 25g x 1-1/8", Blunt Disposable Cannula
Published
2023-06-30
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
OKSLacrimal Stents And Intubation Sets

Product Code Classifications

CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845819006099PackageGS110In Commercial Distribution
00845819006092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900609910845819006099
00845819006092008458190060928458190060920845819006092

GMDN Terms

TermDefinition
Lacrimal intubation setA collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. 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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10845819000141SOFT PLUG® Silicone Punctum Plug6612-SFC, 6612-FC2023-06-30
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