Aptimax Instrument TRAY for ULTRA GI Cycle

GUDID 10705037067190

Instrument Tray, Reusable

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Instrument tray, reusable
Primary Device ID10705037067190
NIH Device Record Key4a04898f-6ad0-4bd9-922e-a1a1232592f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAptimax Instrument TRAY for ULTRA GI Cycle
Version Model Number011077
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705037067190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-03
Device Publish Date2024-09-25

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

10705037067190 - Aptimax Instrument TRAY for ULTRA GI Cycle2024-10-03Instrument Tray, Reusable
10705037067190 - Aptimax Instrument TRAY for ULTRA GI Cycle2024-10-03 Instrument Tray, Reusable
10705037068425 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle2024-10-03 Plasma Sterilizer
10705037068432 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle2024-10-03 Plasma Sterilizer
10705037069583 - ULTRA GI Cycle Validation Kit2024-10-03 STERRAD 100NX System ULTRA GI Cycle Validation Kit
20705037069368 - ULTRA GI Process Challenge Device (PCD) Vial2024-10-03 ULTRA GI Cycle Process Challenge Device Vial
10705037069316 - Evotech2024-06-28 Channel Connector Tube, Orange
10705037068685 - Evotech2024-02-23 Channel Separator, PNTX
10705037069309 - Evotech2024-02-23 Channel Connector Tube, Brown

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