FDA UDI
In Commercial Distribution
🇺🇸 United States
ReliaTect® Post-Op Dressing with CHG
DI: 00817138010500
·
Model: 0496-0567-76
·
AVERY DENNISON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ReliaTect® Post-Op Dressing with CHG
- Primary DI
- 00817138010500
- Version / Model
- 0496-0567-76
- Company Name
- AVERY DENNISON CORPORATION
- Labeler DUNS
- 965754331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 843f5716-67ed-4254-b0ab-c8eefe498c32
Device Description
ReliaTect® Post-Op Dressing with CHG, Small, 3.2 x 5.9 in (8 x 15 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 48124 | Exudate-absorbent dressing, non-gel, antimicrobial | A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817138010507 | GS1 | Secondary (Carton) | 5 | In Commercial Distribution | |
| Primary | 00817138010500 | GS1 | ||||
| Package | 20817138010504 | GS1 | Tertiary (Shipper) | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163529 | 000 |