FDA UDI
In Commercial Distribution
🇺🇸 United States
InterDry
DI: 00311701068825
·
Model: 7910
·
COLOPLAST CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- InterDry
- Primary DI
- 00311701068825
- Version / Model
- 7910
- Catalog Number
- 7910
- Company Name
- COLOPLAST CORP.
- Labeler DUNS
- 847436391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-09
- Public Version
- 3
- Public Version Date
- 2023-01-06
- Public Version Status
- Update
- Public Device Record Key
- 5e612236-2b3e-4c63-a937-9fb8740e871e
Device Description
InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 144 in by 10 in
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | FIBER, MEDICAL, ABSORBENT | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62291 | Antimicrobial skin friction/moisture control fabric, single-patient reusable | A non-sterile absorbent textile material intended to be applied in skin folds or where skin-to-skin contact occurs (e.g., armpits, under the breasts, stomach, groin, and between fingers or toes) to prevent or reduce skin-to-skin friction, moisture, and irritation/inflammation; it is not intended to be used on open wounds. It is made of natural and/or synthetic materials and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00311701068726 | GS1 | Shipper Box | 10 | In Commercial Distribution | |
| Primary | 00311701068825 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110715 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Inch | |
| Length | 144 | Inch |