FDA UDI
In Commercial Distribution
🇺🇸 United States
GoldenDent
DI: 00850011211786
·
Model: GO-SIK
·
GoldenDent
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GoldenDent
- Primary DI
- 00850011211786
- Version / Model
- GO-SIK
- Catalog Number
- GO-SIK
- Company Name
- GoldenDent
- Labeler DUNS
- 078273228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-25
- Public Version
- 1
- Public Version Date
- 2021-03-05
- Public Version Status
- New
- Public Device Record Key
- dc037628-ad90-46e5-9234-d9f6cff023b2
Device Description
Separators Intro Kit (GO-SS1, GO-SS2, GO-SS3, GO- SS4, GO-SS5, GO SS6, GO SS7)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EMJ | ELEVATOR, SURGICAL, DENTAL | Dental | 872.4565 | 1 |
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31814 | Dental dressing forceps, reusable | A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device. | No | Active |
| 16480 | Dental elevator, tooth/root | A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011211786 | GS1 |