FDA.report

Kaiser Permanente Kit Pack

Primary DI
10845819006198
Brand
Kaiser Permanente Kit Pack
Company
OASIS MEDICAL, INC.
Model
KP-4705-SP, B-KP-4705-SP
Device description
Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 3 eaches of Anterior Chamber Cannula, 27g x 7/8", 8mm Bend (GTIN: 00845819001448) 1 eaches of Subtenon Cannula, 19g x 1”, Flattened (GTIN: 00845819006054) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8" (GTIN: 00845819001479) 1 eaches of Hydrodissection Cannula, 25g x 7/8”, 8mm Bend (GTIN: 00845819001516)
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

Related Records

Contact Domains

Product Codes

CodeName
PZGSurgical Eye Tray

Product Code Classifications

CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845819006198PackageGS120In Commercial Distribution
00845819006191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900619810845819006198
00845819006191008458190061918458190061910845819006191

GMDN Terms

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
Radiation Sterilization

Contacts

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

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