FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterling Medical Products
DI: 00685404001039
·
Model: N1197
·
APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterling Medical Products
- Primary DI
- 00685404001039
- Version / Model
- N1197
- Company Name
- APOLLO MEDICAL PRODUCTS CORP.
- Labeler DUNS
- 116768422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-17
- Public Version
- 1
- Public Version Date
- 2019-07-25
- Public Version Status
- New
- Public Device Record Key
- e91292a4-10c9-4567-b77f-39c44d38a6b9
Device Description
COTTON BALLS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63282 | Cotton wool ball, sterile | A sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10685404001036 | GS1 | Carton | 100 | In Commercial Distribution | |
| Primary | 00685404001039 | GS1 |
Customer Contacts
- Phone
- 815-537-5303
- [email protected]