FDA UDI
In Commercial Distribution
🇺🇸 United States
Medicom SafeSeal
DI: 10686864061165
·
Model: ST3001
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Medicom SafeSeal
- Primary DI
- 10686864061165
- Version / Model
- ST3001
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-20
- Public Version
- 1
- Public Version Date
- 2025-03-28
- Public Version Status
- New
- Public Device Record Key
- 65dd0cdd-97f5-4443-af62-f9c6cf814aed
Device Description
Medicom SafeSeal Tan Steam Sterilization Indicator Tape - 0.75" x 60 yards
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20686864061162 | GS1 | Outer Case | 48 | In Commercial Distribution | |
| Primary | 10686864061165 | GS1 |
Customer Contacts
- Phone
- 1(514)636-6262
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171823 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature: 15-30°C, Humidity <50%RH