FDA UDI
In Commercial Distribution
🇺🇸 United States
Snowden-Pencer
DI: 10885403184130
·
Model: SP8301
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Snowden-Pencer
- Primary DI
- 10885403184130
- Version / Model
- SP8301
- Catalog Number
- SP8301
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-17
- Public Version
- 3
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 2526d0a7-6bf6-4653-aeca-6598ae03948f
Device Description
Snowden-Pencer MIS SCISSORS INSERT, CVD METZ 36CM, 10/BOX
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
- 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
- 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 |
|---|---|---|---|---|
| 45918 | Hand-held surgical retractor, reusable | A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885403184137 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10885403184130 | GS1 | ||||
| Package | 50885403184138 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]