Advanced Sterilization Products, STERRAD, APTIMAX Instrument Tray Kit

GUDID 20705037047618

Instrument Tray Kit

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Instrument tray, reusable
Primary Device ID20705037047618
NIH Device Record Key73011624-2159-405c-a1a0-e34e23e25aaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Sterilization Products, STERRAD, APTIMAX Instrument Tray Kit
Version Model Number13839-50
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS120705037047618 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-13
Device Publish Date2022-10-05

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

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20705037015969 - Tyvek®2025-12-25 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 300 mm x 650 mm (12" x 25.5")
20705037015914 - Tyvek®2025-12-24 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 500 mm (8" x 20")
20705037018069 - ENZOL™2025-12-24 ENZOL™ Enzymatic Detergent - 1 Gallon
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