FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653202690
·
Model: JK090
·
Aesculap AG
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653202690
- Version / Model
- JK090
- Catalog Number
- JK090
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 9
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- f5871d8c-1042-40a0-a25a-0111abb28c48
Device Description
Reusable Filter, package of 10 pieces, diam. 190 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KCT | Sterilization wrap containers, trays, cassettes & other accessories | General Hospital | 880.6850 | 2 |
| FLE | Sterilizer, steam | General Hospital | 880.6880 | 2 |
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66887 | Sterilization container filter, reusable | A device designed to function as a microbial barrier in containers used for steam sterilization. It allows penetration of steam as it prevents the passage of microorganisms. It is typically made of a synthetic polymer material [e.g., polytetrafluorethylene (PTFE)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653202690 | GS1 | ||||
| Unit of Use | 04038653341788 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]