FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864043994
·
Model: 83867XR
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864043994
- Version / Model
- 83867XR
- Catalog Number
- 83867XR
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-01-15
- Public Version
- 2
- Public Version Date
- 2023-09-29
- Public Version Status
- Update
- Public Device Record Key
- d6a9ca35-be3f-430e-803b-6539156bf80d
- Distribution End Date
- 2023-09-28
Device Description
AMD-RITMED COTTON BALL STRUNG X-RAY DETECTABLE 1/8 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 |
|---|---|---|---|---|
| GDY | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63281 | Cotton wool ball | A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864043991 | GS1 | Outer Case | 240 | Not in Commercial Distribution | 2023-09-28 |
| Primary | 10686864043994 | GS1 | ||||
| Unit of Use | 00686864043997 | 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 | 1/8 Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place