FDA UDI
In Commercial Distribution
🇺🇸 United States
ITL Essentials™ Needle Mat (Sterile)
DI: 19555240401080
·
Model: A500101
·
ITL ASIA PACIFIC SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ITL Essentials™ Needle Mat (Sterile)
- Primary DI
- 19555240401080
- Version / Model
- A500101
- Catalog Number
- A500101
- Company Name
- ITL ASIA PACIFIC SDN. BHD.
- Labeler DUNS
- 597723837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-20
- Public Version
- 2
- Public Version Date
- 2020-10-21
- Public Version Status
- Update
- Public Device Record Key
- a9f51e82-7132-48ef-83ad-fac2cd717e8e
Device Description
ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 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 | 19555240401370 | GS1 | Inner Box | 16 | In Commercial Distribution | |
| Primary | 19555240401080 | GS1 | ||||
| Package | 19555240401097 | GS1 | Carton | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +18884112851
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Direct Sunlight