FDA UDI
In Commercial Distribution
🇺🇸 United States
LATITUDE® Communicator with Wand
DI: 00802526480485
·
Model: 6481
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LATITUDE® Communicator with Wand
- Primary DI
- 00802526480485
- Version / Model
- 6481
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 106295384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fb6e8752-6faa-4088-a903-197555acea8c
Device Description
LATITUDE ® Communicator with Wand
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42259 | Multi-hole nuclear medicine system collimator, high-energy | A device designed specifically for use in gamma camera or single photon emission computed tomography (SPECT) based planar positron imaging applications operating with an energy range above 500 kilo-electronvolt (keV). It consists of an array of small openings drilled or cast into a flat sheet or plate of lead or lead-equivalent materials. Its size and shape is intended to conform to the crystal shape of a nuclear medicine imaging system to ensure that only gamma ray activity directly in front of the collimator channels in the array reaches the scintillation. It has attachment mechanisms that enable it to be safely transported, removed from, and attached to the detector head of the system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526480485 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P910077 | 123 |