FDA UDI
In Commercial Distribution
🇺🇸 United States
iMed Technology Anchor Dry 10x12
DI: 00850010866109
·
Model: iMed 10x12
·
Imed Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
98
Basic Information
- Brand Name
- iMed Technology Anchor Dry 10x12
- Primary DI
- 00850010866109
- Version / Model
- iMed 10x12
- Company Name
- Imed Technology, Inc.
- Labeler DUNS
- 087974775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 98
- Record Status
- Published
- Publish Date
- 2024-12-28
- Public Version
- 2
- Public Version Date
- 2025-03-26
- Public Version Status
- Update
- Public Device Record Key
- fc41bda3-8121-4c19-b2b1-4eac34522a7b
Device Description
iMed Anchor Dry 10x12 Inner Box
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33536 | Cast/bandage waterproof bathing cover, single-use | A device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850010866093 | GS1 | ||||
| Primary | 00850010866109 | GS1 |