FDA.reportPublic FDA data

Pro-Paks

Primary DI
10810003224092
Brand
Pro-Paks
Company
MICROSPECIALITIES, INC.
Model
219026B
Catalog number
219026B
Device description
Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack.
Published
2022-03-16
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
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810003224092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081000322409210810003224092

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-874-1832customerservice@pro-paks.com

Regulatory Flags#

DUNS number
013469890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30810003221040NAMK-100100MK-1001002019-02-13
30810003221057NAMK-100100-10MK-100100-102019-02-13
30810003221064NAMK-100100-20MK-100100-202019-02-13
30810003221071NAMK-100100-30MK-100100-302019-02-13
30810003221088NAMK-100100-40MK-100100-402019-02-13
30810003221095NAMK-100100+10MK-100100+102019-02-13
30810003221101NAMK-100100+20MK-100100+202019-02-13
30810003221118NAMK-101101 MK-101101 2019-02-13
30810003221125NAMK-101101-10MK-101101-102019-02-13
30810003221132NAMK-101101-20MK-101101-202019-02-13
30810003221149NAMK-101101-30MK-101101-302019-02-13
30810003221156NAMK-101101-40MK-101101-402019-02-13
30810003221163NAMK-101101+10MK-101101+102019-02-13
30810003221170NAMK-101101+20MK-101101+202019-02-13
30810003221330NAMK-200200MK-2002002019-01-03
30810003221521NAMK-300300MK-3003002019-01-03
30810003221958NAMK-500500MK-5005002019-01-03
30810003222139NAMK-600600MK-6006002019-01-03
30810003222146NAMK-600600-10MK-600600-102019-01-03
30810003222153NAMK-600600-20MK-600600-202019-01-03

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Primary DI, Brand, Company table
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