FDA.reportPublic FDA data

Kaiser Permanente Kit Pack

Primary DI
00845819005842
Brand
Kaiser Permanente Kit Pack
Company
OASIS MEDICAL, INC.
Model
KP-4713-SP, B-KP-4713-SP
Device description
"Procedure Packs Assembled from Non-Sterile Capped (NSC) Product1 eaches of Hydrodissection Cannula, 27g x 3/4”, 1mm Bend (GTIN: 00845819001530)1 eaches of A/C Washout Cannula, 19g x 1"", 8mm Bend, Flattened (GTIN: 00845819001592)1 eaches of Anterior Chamber Cannula, 27g x 7/8"", 4mm Bend (GTIN: 00845819001455)1 eaches of Anterior Chamber Cannula, 27g x 7/8"", 8mm Bend (GTIN: 00845819001448)1 eaches of Irrigating Cystotome, Formed, 25g x 5/8"" (GTIN: 00845819001479)"
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
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819005849PackageGS120In Commercial Distribution
00845819005842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900584910845819005849
00845819005842008458190058428458190058420845819005842

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
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
16942748415375AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-11-03
16942748496336AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-10-28
16942748430514AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-10-15
05056785304678Enucleation Kit - Vision GiftBLINK MEDICAL LIMITEDPZG2026-09-25
05056785304555Cannula Kit 1 - San JoseBLINK MEDICAL LIMITEDPZG2026-07-31
16931918180090InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-07-28
05404027449708Accord SetHasa OptixPZG2026-07-16
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