FDA UDI
In Commercial Distribution
🇺🇸 United States
CASPAR DRILL GUIDE
DI: 00192896037267
·
Model: 416-340
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CASPAR DRILL GUIDE
- Primary DI
- 00192896037267
- Version / Model
- 416-340
- Catalog Number
- 416-340
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-18
- Public Version
- 1
- Public Version Date
- 2018-10-19
- Public Version Status
- New
- Public Device Record Key
- 96acd0d3-9a4b-4926-8931-43ca1b495fc0
Device Description
CASPAR DRILL GUIDE RIGHT HANDED
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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48013 | Ophthalmic surgical instrument handle quick lock adaptor | A connecting device designed to allow the attachment of an ophthalmic surgical instrument tip to an ophthalmic surgical instrument handle. It is typically in the form of a small, stainless steel, circular adaptor with a threaded interface that attaches to a threaded portion of the handle and provides a quick lock mechanism (e.g., bayonet fitting) that secures/releases the inserted tip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896037267 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 65 Degree Tip |