FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Snowden-Pencer
DI: 10885403067877
·
Model: 89-8462
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Snowden-Pencer
- Primary DI
- 10885403067877
- Version / Model
- 89-8462
- Catalog Number
- 89-8462
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-06
- Public Version
- 4
- Public Version Date
- 2022-03-04
- Public Version Status
- Update
- Public Device Record Key
- 4e66f04e-86eb-4f48-80bf-2e6ba86ee3b3
- Distribution End Date
- 2021-04-22
Device Description
Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE SWEATBAND WITH 3.5MM X 9FT BIFURCATED FIBER OPTIC CABLE
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
- No
- 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 |
|---|---|---|---|---|
| EBA | LIGHT, SURGICAL HEADLIGHT | Dental | 872.4630 | 1 |
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 | 10885403067877 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
- Phone
- +1(800)323-9088
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893458 | 000 |