FDA UDI
In Commercial Distribution
🇺🇸 United States
View Guard Transparent Film Dressing Roll
DI: 00616784364018
·
Model: 3640
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- View Guard Transparent Film Dressing Roll
- Primary DI
- 00616784364018
- Version / Model
- 3640
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 1
- Public Version Date
- 2021-06-29
- Public Version Status
- New
- Public Device Record Key
- 6f35393d-9956-4548-8ed6-a86740bcdf14
Device Description
View Guard Transparent Film Dressing Roll; Semi-Permeable, Non-Sterile, 4"x11yds
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58300 | Synthetic polymer semi-permeable film dressing, adhesive, non-sterile | A non-sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to skin typically intended to fix a primary dressing or a medical device (e.g. drainage tube), or to provide protection from fluids. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784364032 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00616784364018 | GS1 |