FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKSLacrimal Stents And Intubation Sets

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819006099PackageGS110In Commercial Distribution
00845819006092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900609910845819006099
00845819006092008458190060928458190060920845819006092

GMDN Terms#

Term, Definition table
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 table
Method
Radiation Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845819082003Oasis REST & RELIEF Single-UseOM82002026-08-14
00845819083000Oasis REST & RELIEF Plus Single-UseOM83002026-08-14
00845819006344Surgeon's Choice CardSCK 2004, B-SCK 20042023-06-30
00845819006375Surgeon's Choice CardSCK 2005, B-SCK 20052023-06-30
10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
10845819005474SOFT PLUG® Extended Duration Plugs 5032023-06-30
10845819005498SOFT PLUG® Extended Duration Plugs 5052023-06-30
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
00845819003138Surgeon's Choice CardSCK-2012, B-SCK-20122025-10-02
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
00845819002919Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
00845819002926Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
00845819002988Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002971Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
10845819002985Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002322Premier Edge® Microsurgical KnivesPE4827-TL, B-PE4827-TL2023-04-30
00845819000267SOFT PLUG® Extended Duration Plugs 6400V2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET FCI S A S FCI 20 22OKS2026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732088STOPLOSS® JONES TUBE 4 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732095STOPLOSS® JONES TUBE 4 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732101STOPLOSS® JONES TUBE 4 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732118STOPLOSS® JONES TUBE 4 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732125STOPLOSS® JONES TUBE 4 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732132STOPLOSS® JONES TUBE 4 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732149STOPLOSS® JONES TUBE 4 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732156STOPLOSS® JONES TUBE 4 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732163STOPLOSS® JONES TUBE 4 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773735072STOPLOSS® JONES TUBE REMOVAL TOOL FCI S A S FCI 20 22OKS2026-04-20