FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864044731
·
Model: A4061-TLFS
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864044731
- Version / Model
- A4061-TLFS
- Catalog Number
- A4061-TLFS
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-13
- Public Version
- 3
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- c3447d1f-5189-4daf-b7b3-3b93d34b8669
- Distribution End Date
- 2023-11-16
Device Description
AMD-RITMED COHESIVE BANDAGE ROLL 4 Inch X 5 Yard
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
- 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 |
|---|---|---|---|---|
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58964 | Non-adhesive device retention bandage | A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864044738 | GS1 | Outer Case | 18 | Not in Commercial Distribution | 2023-11-16 |
| Primary | 10686864044731 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262
- [email protected]
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4 Inch X 5 Yard |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place