FDA UDI
In Commercial Distribution
🇺🇸 United States
STAT-PAC™
DI: 10076490616653
·
Model: 361102REG
·
Ansell Healthcare Product
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STAT-PAC™
- Primary DI
- 10076490616653
- Version / Model
- 361102REG
- Catalog Number
- 361102REG
- Company Name
- Ansell Healthcare Product
- Labeler DUNS
- 111267330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-21
- Public Version
- 1
- Public Version Date
- 2022-03-29
- Public Version Status
- New
- Public Device Record Key
- c8a68480-4709-4d46-a4a6-5bf51f67f0c3
Device Description
Room Turnover Pack
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
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65175 | Operating room turnover kit | A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20076490617398 | GS1 | Case | 15 | In Commercial Distribution | |
| Primary | 10076490616653 | GS1 |
Customer Contacts
- Phone
- 775-746-6600
- [email protected]
- Phone
- 775-470-7106
- [email protected]