FDA.reportPublic FDA data

Aptimax

Primary DI
20705037016010
Brand
Aptimax
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
13826
Catalog number
13826
Device description
Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013003000APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDERAdvanced Sterilization Products2002-08-28FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037016010PackageGS12In Commercial Distribution
10705037016013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503701601020705037016010
1070503701601310705037016013

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Trays shall be stored in inside warehousing at ambient temperature and humidity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723complaints@aspus.jnj.com
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
947451626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10705037048717ASP AEROFLEX™28000280002019-07-31
10705037030958EVOTECH™50004500042016-09-24
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037000562EVOTECH™010460101046012018-05-31
10705037045006EVOTECH™010410101041012016-09-24
10705037016495STERRAD™20228202282016-09-24
10705037016198STERRAD™14100141002016-09-24
10705037014132STERRAD NX™10033100332016-09-24
10705037016952STERRAD™21005210052018-05-31
10705037016211Cyclesure14324143242016-09-24
10705037044580CIDEX™226622662016-09-24
10705037012602EVOTECH™8450018450012016-09-24
10705037068753ASP AEROFLEX™911902891190282022-10-25
10705037047611APTIMAX™13839138392016-09-24
10705037071319ULTRA GI™43381433812025-12-15
10705037042999STERRAD™99204992042026-06-03
10705037043002STERRAD™99205992052018-05-31
10705037043019STERRAD™99206992062018-05-31
10705037043026STERRAD™99207992072018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535037654Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
08404535037685Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
00724995239985V. MuellerSteris CorporationFRG2026-10-15
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20884389188269GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115597GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
10884389192481GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196180810GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921093GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921116GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190419GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277115580GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190471GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26