FDA UDI
In Commercial Distribution
🇺🇸 United States
Juzo Soft Seamless
DI: 00640095309727
·
Model: 2000ACLE01 XL
·
Julius Zorn, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Juzo Soft Seamless
- Primary DI
- 00640095309727
- Version / Model
- 2000ACLE01 XL
- Catalog Number
- 30972
- 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
- 35879ef5-0825-4537-8398-4b264c271458
Device Description
15-20 mmHg, Soft, Seamless Gauntlet, Left, Prints, XL
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
- 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
- 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 |
|---|---|---|---|---|
| IOY | SUPPORT, ARM | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16500 | Compression/pressure glove | A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00640095309727 | GS1 |
Customer Contacts
- Phone
- +1(800)222-4999
- [email protected]