FDA UDI
In Commercial Distribution
🇺🇸 United States
TC plate 96 well, BIOFLOAT™,R
DI: 04038917923965
·
Model: 83.3925.400
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- TC plate 96 well, BIOFLOAT™,R
- Primary DI
- 04038917923965
- Version / Model
- 83.3925.400
- Catalog Number
- 83.3925.400
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 3
- Public Version Date
- 2023-08-18
- Public Version Status
- Update
- Public Device Record Key
- 54c5fa58-0eb9-4efc-a1a6-2aeb5c43288d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIZ | DISH, TISSUE CULTURE | Hematology | 864.2240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43344 | Tissue culture/microbiology petri dish, single-use | A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04038917923958 | GS1 | ||||
| Primary | 04038917923965 | GS1 |
Customer Contacts
- Phone
- +1(800)257-5101
- [email protected]