FDA UDI
In Commercial Distribution
🇺🇸 United States
Tatum Integrity Implant Kit
DI: 00083208422225
·
Model: Master Integrity Implant Kit 3.7-8.0
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tatum Integrity Implant Kit
- Primary DI
- 00083208422225
- Version / Model
- Master Integrity Implant Kit 3.7-8.0
- Catalog Number
- ASY ITI Kit Master
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 1
- Public Version Date
- 2020-08-10
- Public Version Status
- New
- Public Device Record Key
- e70a79bc-f49f-4524-8daf-db0d29f74503
Device Description
Tatum Integrity Implant kit: A kit designed for simplicity and ease of use in placing Tatum Integrity Implants: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.5x11, 14, 17, 20, DR4.0x11, 14, 17, 20, DR4.5x11,14,17, 20, DR5.0x11, 14, 17, 20, DR6.0x11,14,17,20. DR7.0x11, 14,17. DR8.0x11, 14, 17. HT.02, 03, 03L, 06, 06L, 07, 07L, 08, 09, 09L, 26, 27, 29, & 30. Tatum Ratchet, set of 4 paralleling pins. Autoclaveable Cassette/Container for all pieces
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083208422225 | GS1 |
Customer Contacts
- Phone
- 727-536-4880
- [email protected]