FDA UDI
In Commercial Distribution
🇺🇸 United States
Perma Block
DI: 00842092112298
·
Model: 5851006
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Perma Block
- Primary DI
- 00842092112298
- Version / Model
- 5851006
- Catalog Number
- 5851006
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 4
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 2ccd4dd0-128b-4742-b578-a55e2a259023
Device Description
Perma Block E-Z Gun
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBH | MATERIAL, IMPRESSION TRAY, RESIN | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60266 | Sweat-induction iontophoresis system generator | A battery-powered, portable component of a sweat-induction iontophoresis system intended to produce a variable low-voltage current (e.g., 1.5mA) to induce sweating by facilitating the transcutaneous introduction of water-soluble electrolytic substances, typically containing pilocarpine, via applied skin electrodes. It typically functions automatically and is primarily used in the diagnosis of cystic fibrosis (CF). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092112298 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]