FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXITEST
DI: 00304040002483
·
Model: 1048993
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MAXITEST
- Primary DI
- 00304040002483
- Version / Model
- 1048993
- Catalog Number
- 1048993
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 392f9ff5-556e-4800-bb6a-d21b12e1d01c
Device Description
Steam Indicator Tape
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10304040002480 | GS1 | ROLL | 36 | In Commercial Distribution | |
| Primary | 00304040002483 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- controlled room temperature