FDA UDI
In Commercial Distribution
🇺🇸 United States
iDrive
DI: 10884521139275
·
Model: IDRVBIG
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iDrive
- Primary DI
- 10884521139275
- Version / Model
- IDRVBIG
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-02
- Public Version
- 7
- Public Version Date
- 2023-09-22
- Public Version Status
- Update
- Public Device Record Key
- 81c82f22-aa4b-460a-b908-9e7f80003bfd
Device Description
Battery Insertion Guide
Device Characteristics
- Single Use
- No
- 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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDW | STAPLE, IMPLANTABLE | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60486 | Surgical instrument battery insertion guide | A non-sterile device intended to protect a sterile, battery-powered surgical instrument during insertion of a non-sterile battery such that the sterility of the surgical instrument is maintained; it may be intended for use preoperatively and/or during surgery. It is typically a shaped template which is designed to fit and cover the profile of the battery insertion port. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521139275 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 279 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit