FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptimax
DI: 10705037048649
·
Model: 13841
·
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aptimax
- Primary DI
- 10705037048649
- Version / Model
- 13841
- Catalog Number
- 13841
- Company Name
- ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Labeler DUNS
- 947451626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 11
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- d676ac4a-64c2-4ac5-b2d0-290d3ab2566a
Device Description
Instrument Tray Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705037048649 | GS1 |
Customer Contacts
- Phone
- +1(888)783-7723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013003 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius