FDA UDI
In Commercial Distribution
🇺🇸 United States
70424 Needle Counter 1/2 Adhesive 1/2 Foam Block 20-40 Count w/ Blade Remover
DI: 00787551009736
·
Model: 70424
·
XODUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 70424 Needle Counter 1/2 Adhesive 1/2 Foam Block 20-40 Count w/ Blade Remover
- Primary DI
- 00787551009736
- Version / Model
- 70424
- Catalog Number
- 70424
- Company Name
- XODUS MEDICAL, INC.
- Labeler DUNS
- 868042664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- ee6cb8b1-0438-4d34-92ba-5b3906f42199
Device Description
70424 Needle Counter 1/2 Adhesive 1/2 Foam Block 20-40 Count w/ Blade Remover
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAB | NEEDLE, SUTURING, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61634 | Sharp surgical instrument counting tray/pad, single-use | A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10787551009733 | GS1 | BOX | 8 | In Commercial Distribution | |
| Primary | 00787551009736 | GS1 | ||||
| Package | 20787551009730 | GS1 | CASE | 64 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(724)337-5500
- [email protected]