FDA UDI
In Commercial Distribution
🇺🇸 United States
ProChek ID
DI: H816PIT3401
·
Model: PIT340
·
CERTOL INTERNATIONAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ProChek ID
- Primary DI
- H816PIT3401
- Version / Model
- PIT340
- Catalog Number
- PIT340-1
- Company Name
- CERTOL INTERNATIONAL, LLC
- Labeler DUNS
- 095153714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-13
- Public Version
- 5
- Public Version Date
- 2022-11-01
- Public Version Status
- Update
- Public Device Record Key
- 99bb013f-a374-4d05-a645-54be25c5d877
Device Description
Steam Sterilization Indicator Tape
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
- 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 |
|---|---|---|---|---|
| LRT | Indicator, Sterilization | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44427 | Sterilization packaging tape | A non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H816PIT3401 | HIBCC | ||||
| Package | H816PIT3402 | HIBCC | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951113 | 000 |