FDA.reportPublic FDA data

Kaiser Permanente Kit Pack

Primary DI
10845819006211
Brand
Kaiser Permanente Kit Pack
Company
OASIS MEDICAL, INC.
Model
KP-4707-SP, B-KP-4707-SP
Device description
Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 3 eaches of Anterior Chamber Cannula, 27g x 7/8", 6mm Bend (GTIN: 00845819001462) 1 eaches of Irrigating Cystotome, Formed 27g x 5/8" (GTIN: 00845819006078) 1 eaches of A/C Washout Cannula, 19g x 1", 8mm Bend, Flattened (GTIN: 00845819001592) 1 eaches of Hydrodissection Cannula, 27g x 3/4”, 1mm Bend (GTIN: 00845819001530)
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
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819006211PackageGS120In Commercial Distribution
00845819006214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900621110845819006211
00845819006214008458190062148458190062140845819006214

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
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

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00845819020111Surgeon's Choice CardOASIS MEDICAL, INC.PZG2024-11-07
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30886158003589READYPAKBeaver-Visitec International, Inc.PZG2024-06-27
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