FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HCS
DI: 00849027003454
·
Model: HCS5031-25LF
·
DYAD MEDICAL SOURCING, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- HCS
- Primary DI
- 00849027003454
- Version / Model
- HCS5031-25LF
- Company Name
- DYAD MEDICAL SOURCING, LLC
- Labeler DUNS
- 078572603
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 3
- Public Version Date
- 2025-12-10
- Public Version Status
- Update
- Public Device Record Key
- edf29ba3-f741-45ae-bb04-df7b91aa6e4a
- Distribution End Date
- 2022-09-30
Device Description
2” x 4.5 yd Elastic Bandage w/Clasp Closure, Non-Sterile, Latex-Free
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13369 | Skin treatment/dressing-supportive limb/finger bandage, single-use | An elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849027003451 | GS1 | case | 5 | Not in Commercial Distribution | 2022-09-30 |
| Primary | 00849027003454 | GS1 | ||||
| Unit of Use | 20849027003458 | GS1 |