FDA UDI
In Commercial Distribution
🇺🇸 United States
Endeavour™ TruColor™
DI: 00850036373759
·
Model: 922010-3
·
METREX RESEARCH, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endeavour™ TruColor™
- Primary DI
- 00850036373759
- Version / Model
- 922010-3
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-12
- Public Version
- 1
- Public Version Date
- 2024-09-20
- Public Version Status
- New
- Public Device Record Key
- fa3c9c9f-cc10-4d3d-aec2-1dcdd706b545
Device Description
Endeavour™ TruColor™ battery pack replacement kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 36534 | Portable/mobile rechargeable battery pack | A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850036373759 | GS1 |
Customer Contacts
- Phone
- 1.800.369.3698
- [email protected]