FDA UDI
In Commercial Distribution
🇺🇸 United States
HydroTac transparent comf. 8x8cm st P10
DI: 04049500835039
·
Model: 6859206 HydroTac transparent comf. 8x8cm st P10
·
PAUL HARTMANN AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HydroTac transparent comf. 8x8cm st P10
- Primary DI
- 04049500835039
- Version / Model
- 6859206 HydroTac transparent comf. 8x8cm st P10
- Company Name
- PAUL HARTMANN AG
- Labeler DUNS
- 315768788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 3
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 571a4fd6-66f2-4935-a0ed-a624990761f3
Device Description
HydroTac transparent comf. 8x8cm st P10
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
- Yes
- 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 |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04049500835046 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04049500835039 | GS1 | ||||
| Package | 04049500835053 | GS1 | 8 | In Commercial Distribution |