FDA UDI
In Commercial Distribution
🇺🇸 United States
Snowden-Pencer
DI: 10885403285462
·
Model: 89-7204
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Snowden-Pencer
- Primary DI
- 10885403285462
- Version / Model
- 89-7204
- Catalog Number
- 897204
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 021599373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-30
- Public Version
- 6
- Public Version Date
- 2024-08-14
- Public Version Status
- Update
- Public Device Record Key
- 5e21ab7d-df8f-4c7f-b486-04098cb9b6f2
Device Description
RESPOSABLE TITANIUM NEEDLE SUCTION ELECTRODE 5MM, 32CM, 5 PER BOX
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
- Yes
- 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 |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 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 |
|---|---|---|---|---|---|---|
| Package | 20885403141680 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 10885403285462 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930666 | 000 |