FDA.reportPublic FDA data

Disposable Instruments

Primary DI
10845819001308
Brand
Disposable Instruments
Company
OASIS MEDICAL, INC.
Model
4042-2S
Device description
Infusion Cannula, 20g x 2mm Long
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819001308PackageGS110In Commercial Distribution
00845819001301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900130810845819001308
00845819001301008458190013018458190013010845819001301

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810163790577Diamatrix Ltd.DiamatrixHMX2026-05-26
00841668145906BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145913BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145920BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145937BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145944BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145951BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146040BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146057BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146088BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146101BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146118BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146125BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146156BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146163BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146187BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146217BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146224BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146255BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145487BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146286BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146293BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146309BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146316BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146323BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146330BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146347BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146354BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146361BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146378BLINKKATENA PRODUCTS, INC.HMX2026-03-23