FDA UDI
In Commercial Distribution
🇺🇸 United States
Acutarex
DI: 05060996770023
·
Model: 4x4
·
Alliance Healing Technologies, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Acutarex
- Primary DI
- 05060996770023
- Version / Model
- 4x4
- Company Name
- Alliance Healing Technologies, LLC
- Labeler DUNS
- 124808420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 196808c6-156e-48d6-909e-38b0d56c460f
Device Description
PDR Ointment Impregnated Gauze Non-Adherent Dressing: 4x4 Gauze
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46855 | Wound-nonadherent dressing, permeable, non-antimicrobial | A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060996770023 | GS1 | ||||
| Package | 05060996770030 | GS1 | Box | 240 | In Commercial Distribution |
Customer Contacts
- Phone
- 603-731-1630
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041059 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch | |
| Width | 4 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit