FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Duo
DI: 10381780490708
·
Model: 90622
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Integra® Duo
- Primary DI
- 10381780490708
- Version / Model
- 90622
- Catalog Number
- 90622
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-11-14
- Public Version
- 6
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- 0293fc7d-0a6c-47c4-8c29-17d62c70d3a3
Device Description
Integra® DUO Lithium Ion Batteries - Quantity Two
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
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSR | Light, headband, surgical | Ophthalmic | 886.4335 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32037 | General-purpose light source | A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780490708 | GS1 | ||||
| Unit of Use | 00381780490701 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 120 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 49 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity