FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOTRACE™
DI: 07798375772624
·
Model: 73135
·
TERRAGENE S.A.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- BIOTRACE™
- Primary DI
- 07798375772624
- Version / Model
- 73135
- Company Name
- TERRAGENE S.A.
- Labeler DUNS
- 970856911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-11-12
- Public Version
- 3
- Public Version Date
- 2025-06-02
- Public Version Status
- Update
- Public Device Record Key
- ac844623-5271-45f0-85f6-5a71481b2cb2
Device Description
BIOTRACE™ Auto Read 60 Steam BI Process Challenge Device
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
- Yes
- 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 |
|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | General Hospital | 880.2800 | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07798375772877 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 07798375772624 | GS1 | ||||
| Unit of Use | 07798375772600 | GS1 |
Customer Contacts
- Phone
- +1(888)783-7723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163646 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity