FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXI-GARD
DI: 10304040139773
·
Model: 5702325
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- MAXI-GARD
- Primary DI
- 10304040139773
- Version / Model
- 5702325
- Catalog Number
- 5702325
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 1
- Public Version Date
- 2021-06-02
- Public Version Status
- New
- Public Device Record Key
- 225a921c-523c-4301-ad26-2f4f4b0cac74
Device Description
Maxi-Gard Jacket Teal
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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LYU | ACCESSORY, SURGICAL APPAREL | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32159 | Assistive jacket | An assistive garment that is specially designed/adapted for use by a person with a disability to be worn on the upper torso and shaped with full-length sleeves, a collar, and an opening at the front. It may be worn by a male or a female and will typically be constructed with features that accommodate the disability, e.g., large buttons, Velcro fasteners, zip fasteners, wide sleeves and large pockets. Coats and jackets for outdoor use are not included in this GMDN code. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040139776 | GS1 | ||||
| Primary | 10304040139773 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place, avoid sunlight.