FDA UDI
In Commercial Distribution
🇺🇸 United States
Snowden-Pencer
DI: 10885403146107
·
Model: 32-3004
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Snowden-Pencer
- Primary DI
- 10885403146107
- Version / Model
- 32-3004
- Catalog Number
- 32-3004
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-12
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- e7be99db-c286-438f-81fb-409fa373763c
Device Description
Snowden-Pencer Plastics DIAMOND-TIP RASPS FOMON 21,5CM (8-1/2"), GRIT #3 AND #4
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
- Yes
- 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 |
|---|---|---|---|---|
| GAC | RASP, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13291 | Plastic surgery file/rasp | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It is typically a one-piece instrument which resembles a coarse or fine file, but with sharp cutting projections instead of lines and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403146107 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]