FDA UDI
In Commercial Distribution
🇺🇸 United States
EO Chex 1" Indicator Tape - 36 rolls/case
DI: 70818087011081
·
Model: 26811600
·
PROPPER MANUFACTURING COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
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Basic Information
- Brand Name
- EO Chex 1" Indicator Tape - 36 rolls/case
- Primary DI
- 70818087011081
- Version / Model
- 26811600
- Catalog Number
- 26811600
- Company Name
- PROPPER MANUFACTURING COMPANY, INC.
- Labeler DUNS
- 001483130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2024-07-26
- Public Version
- 2
- Public Version Date
- 2025-02-21
- Public Version Status
- Update
- Public Device Record Key
- 3457a1c9-b83c-4497-ad61-4f9eff761069
Device Description
EO Chex 1" Indicator Tape - 36 rolls/case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 (non-electrical) 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10818087011089 | GS1 | ||||
| Primary | 70818087011081 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240910 | 000 |