FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGICAL INSTRUMENT
DI: 07899995298539
·
Model: CTUCM 65E
·
Sin Sistema de Implante Nacional S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SURGICAL INSTRUMENT
- Primary DI
- 07899995298539
- Version / Model
- CTUCM 65E
- Catalog Number
- CTUCM 65E
- Company Name
- Sin Sistema de Implante Nacional S/A
- Labeler DUNS
- 904569092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-23
- Public Version
- 1
- Public Version Date
- 2021-03-31
- Public Version Status
- New
- Public Device Record Key
- 119fa8a3-8a72-4bbf-8e8e-9f1a7ba7c7a8
Device Description
DRIVE HANDPIECE UNITITE PRIME H6,5 NAR
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47633 | Surgical screwdriver, single-use, non-sterile | A non-sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899995298539 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201688 | 000 |