FDA UDI
In Commercial Distribution
🇺🇸 United States
Juzo Dynamic Silver
DI: 00640095078784
·
Model: 3561CFSSB II
·
Julius Zorn, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Juzo Dynamic Silver
- Primary DI
- 00640095078784
- Version / Model
- 3561CFSSB II
- Catalog Number
- 07878
- Company Name
- Julius Zorn, Inc.
- Labeler DUNS
- 123197535
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-08
- Public Version
- 1
- Public Version Date
- 2023-09-18
- Public Version Status
- New
- Public Device Record Key
- aaa0e07e-ce94-49b4-a286-14e6898ff533
Device Description
20-30 mmHg, Silver, BK Shrinker, 12" / 30 cm, Silicone, II
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IPM | COVER, LIMB | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30878 | Compression/pressure sock/stocking, single-use | A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00640095078784 | GS1 |
Customer Contacts
- Phone
- +1(800)222-4999
- [email protected]