FDA UDI
In Commercial Distribution
🇺🇸 United States
G-Rex
DI: 00850019717037
·
Model: 81100
·
WILSON WOLF MANUFACTURING CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- G-Rex
- Primary DI
- 00850019717037
- Version / Model
- 81100
- Catalog Number
- 81100
- Company Name
- WILSON WOLF MANUFACTURING CORPORATION
- Labeler DUNS
- 170969237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-13
- Public Version
- 1
- Public Version Date
- 2022-09-21
- Public Version Status
- New
- Public Device Record Key
- 1e0b9d3b-55be-4ca5-b46f-074a7c425044
Device Description
G-Rex100M Gas Permeable Cell Culture Product
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KJF | System, Suspension, Cell Culture | Hematology | 864.2240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44904 | Blood/tissue storage/culture container | A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850019717075 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 00850019717037 | GS1 |