FDA UDI
In Commercial Distribution
🇺🇸 United States
Areza Medical
DI: 00850021481728
·
Model: BG8630
·
ADVANCED MEDICAL ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
30
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Basic Information
- Brand Name
- Areza Medical
- Primary DI
- 00850021481728
- Version / Model
- BG8630
- Catalog Number
- BG8630
- Company Name
- ADVANCED MEDICAL ASSOCIATES, LLC
- Labeler DUNS
- 047724226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2024-10-26
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 6b49dd86-042c-4100-a8e1-496aeca93673
Device Description
Areza Island Wound Dressing (Bordered Gauze) is a sterile and self-adhesive dressing. The central pad (6"x4") is made of non-woven viscose fibers with a non-adherent fenestrated layer for wound contact. The backing (8"x6") is composed of polyurethane and Spunlace fabric with adhesive. This dressing is ideal for minimally exuding wounds, reducing the risk of damage and other contaminations. Individually packed and sterile for convenience.
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
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial | A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810147400850 | GS1 | Inner Case | 10 | In Commercial Distribution | |
| Primary | 00850021481728 | GS1 | ||||
| Package | 00810147400867 | GS1 | Case | 20 | In Commercial Distribution | |
| Unit of Use | 00850021481711 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 6 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place. Avoid excessive heat