FDA UDI
In Commercial Distribution
🇺🇸 United States
NEUSTER
DI: 00810105211863
·
Model: TY 203225
·
PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NEUSTER
- Primary DI
- 00810105211863
- Version / Model
- TY 203225
- Company Name
- PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Labeler DUNS
- 565751992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-24
- Public Version
- 1
- Public Version Date
- 2023-02-01
- Public Version Status
- New
- Public Device Record Key
- 5b7a30ca-a136-4b75-b1cc-f204c96a605c
Device Description
Sterilization Roll made of DuPont™ Tyvek® 20,3 cm x 225 m
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 13735 | Sterilization packaging, single-use | A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810105211870 | GS1 | CASE | 2 | In Commercial Distribution | |
| Primary | 00810105211863 | GS1 |
Customer Contacts
- Phone
- +903242387042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160595 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- – 35 Degrees Celsius