FDA.reportPublic FDA data

Surgeon's Choice Card

Primary DI
10845819002985
Brand
Surgeon's Choice Card
Company
OASIS MEDICAL, INC.
Model
SCK 2009, B-SCK 2009
Device description
Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:00845819001448) 1 eaches Cortical Cleaving Hydroissector, 27g x 7/8'', Flat End, 11mm Bend (GTIN:00845819005354) 1 eaches Irrigating Cystotome, 25g x 5/8", Reverse Formed (GTIN:00845819000977)
Published
2023-12-27
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
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819002985PackageGS120In Commercial Distribution
00845819002988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900298510845819002985
00845819002988008458190029888458190029880845819002988

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. 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
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
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
10845819000134SOFT PLUG® Silicone Punctum Plug6612-EP2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056785303657CANNULA KIT 1 - KAISER PERMANENTE MARTINEZBLINK MEDICAL LIMITEDPZG2026-05-12
05056785303633Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2026-05-06
16931918100166InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918103310InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918105574InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
00841668123331KATENAKATENA PRODUCTS, INC.PZG2026-03-02
10841668123338KATENAKATENA PRODUCTS, INC.PZG2026-03-02
05056785303251Cataract Instrument Pack - UCMBLINK MEDICAL LIMITEDPZG2025-12-11
05056785303268Cataract Instrument Pack - UCMBLINK MEDICAL LIMITEDPZG2025-12-11
05056785303015Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303039Cataract Inst Set - Spokane AdamsBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303022Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303046Cataract Inst Set - Spokane AdamsBLINK MEDICAL LIMITEDPZG2025-11-12
05056785302773Cataract Kit – Oklahoma VABLINK MEDICAL LIMITEDPZG2025-10-10
00845819003138Surgeon's Choice CardOASIS MEDICAL, INC.PZG2025-10-02
05056785302599RC Kit 1BLINK MEDICAL LIMITEDPZG2025-09-18
05056785302605RC Kit 1BLINK MEDICAL LIMITEDPZG2025-09-18
05404027449517The Doctor Clinic SetHasa OptixPZG2025-09-12
05404027449524The Doctor Clinic SetHasa OptixPZG2025-09-12
05056785302520RC Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302544Stockton Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302575Stockton Kit 1BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302537RC Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302568Stockton Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302582Stockton Kit 1BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302469Kaiser AMD Instrument SetBLINK MEDICAL LIMITEDPZG2025-08-26
05056785302476Kaiser AMD Instrument SetBLINK MEDICAL LIMITEDPZG2025-08-26
05056785302421Kaiser AMD SetBLINK MEDICAL LIMITEDPZG2025-07-28
05404027449463Cataract Set Rayner 73-Greens ChopperHasa OptixPZG2025-07-22
05404027449470NHS Scotland Cataract Set Rayner 74Hasa OptixPZG2025-07-22