FDA.reportPublic FDA data

Lacrimal lntubation Set

Primary DI
00845819000434
Brand
Lacrimal lntubation Set
Company
OASIS MEDICAL, INC.
Model
6004-27
Device description
Lacrimal lntubation Set, 27g
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10845819000431PackageGS13In Commercial Distribution
00845819000434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900043110845819000431
00845819000434008458190004348458190004340845819000434

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00845819006375Surgeon's Choice CardSCK 2005, B-SCK 20052023-06-30
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
10845819000219SOFT PLUG® Extended Duration Plugs 6402, 6402-A2023-07-31
10845819000097SOFT PLUG® Silicone Punctum Plug6610-EP2023-06-30
10845819000110SOFT PLUG® Silicone Punctum Plug6611-EP2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
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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