FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864044557
·
Model: 89212
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864044557
- Version / Model
- 89212
- Catalog Number
- 89212
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-24
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 8e0360a2-b86c-4c7e-87bc-6f3929414559
- Distribution End Date
- 2023-11-16
Device Description
AMD-RITMED VAGINAL PACKING 2 3/4 X 1 1/2 Inch
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 |
|---|---|---|---|---|
| NAC | Dressing, wound, hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48127 | Woven gauze roll/sheet | A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864044554 | GS1 | Outer Case | 100 | Not in Commercial Distribution | 2023-11-16 |
| Primary | 10686864044557 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 3/4 X 1 1/2 Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place