FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterling Medical Products
DI: 00685404000605
·
Model: 179A
·
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
- 00685404000605
- Version / Model
- 179A
- Company Name
- APOLLO MEDICAL PRODUCTS CORP.
- Labeler DUNS
- 116768422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-01
- Public Version
- 1
- Public Version Date
- 2019-08-09
- Public Version Status
- New
- Public Device Record Key
- ee0bb922-2f92-4a60-a661-3fce88f5c148
Device Description
BIOPSY TRAY
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 |
|---|---|---|---|---|
| 61922 | Soft-tissue biopsy procedure kit, medicated | A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10685404000602 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00685404000605 | GS1 |
Customer Contacts
- Phone
- 815-537-5303
- [email protected]