FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Snowden-Pencer
DI: 10885403225048
·
Model: SP94-8384
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Snowden-Pencer
- Primary DI
- 10885403225048
- Version / Model
- SP94-8384
- Catalog Number
- SP94-8384
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-31
- Public Version
- 3
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- b48d5ebb-d2b1-405c-bca4-6a34bee0aafb
- Distribution End Date
- 2021-03-05
Device Description
Snowden-Pencer MIS WAVY GRASPER ERGONOMIC TAKE APART 5MM, 36CM, ESU COMPLETE INSTRUMENT
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
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33596 | Endoscopic electrosurgical handpiece/electrode, monopolar, reusable | An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403225048 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
- Phone
- +1(800)323-9088
- [email protected]