FDA UDI
Not in Commercial Distribution
🇺🇸 United States
THE BULLET, Alcon, INFINITECH
DI: 00380650109200
·
Model: 8065010920
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- THE BULLET, Alcon, INFINITECH
- Primary DI
- 00380650109200
- Version / Model
- 8065010920
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2024-03-21
- Public Version Status
- Update
- Public Device Record Key
- 49cc1216-4a22-496c-80e3-d19081b2417e
- Distribution End Date
- 2017-12-31
Device Description
The Bullet Endo Illuminator, Wide Angle Tip, 20Ga, 1.8m
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32241 | Fibreoptic operating light system | A system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10380650109207 | GS1 | Box | 10 | Not in Commercial Distribution | 2017-12-31 |
| Primary | 00380650109200 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20 Gauge | ||
| Length | 1.8 | Meter |