FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07630031745231
·
Model: surgically Invasive Instruments
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NA
- Primary DI
- 07630031745231
- Version / Model
- surgically Invasive Instruments
- Catalog Number
- 040.593S
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 3
- Public Version Date
- 2024-12-24
- Public Version Status
- Update
- Public Device Record Key
- b8f12e73-222d-4b35-995c-e6b129f6df14
Device Description
Drill Stop Set, Type E wide, for drill Ø 4.7 - 6.2mm, short 4mm
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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67356 | Surgical instrument/implant depth limiter, single-use | A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit, reamer, electrode), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of stainless steel and/or synthetic polymer materials and is available in a variety of shapes and lengths. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630031745231 | GS1 |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.7 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight