FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 20686864042840
·
Model: 53217
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 20686864042840
- Version / Model
- 53217
- Catalog Number
- 53217
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2019-01-16
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 36b438e8-3a31-4f7c-88b3-a0677f5190a9
- Distribution End Date
- 2023-09-06
Device Description
AMD-RITMED CYLINDRICAL SPONGES X-RAY DETECTABLE 3/8 X 3/4 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDY | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58232 | Cotton wool roll | A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20686864042840 | GS1 | ||||
| Unit of Use | 00686864042846 | 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 | 3/8 X 3/4 Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place