FDA UDI
In Commercial Distribution
🇺🇸 United States
Lexicon GATES Glidden drills Stainless
DI: D716GG5281
·
Model: GG528
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lexicon GATES Glidden drills Stainless
- Primary DI
- D716GG5281
- Version / Model
- GG528
- Catalog Number
- GG528
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-26
- Public Version
- 1
- Public Version Date
- 2022-09-05
- Public Version Status
- New
- Public Device Record Key
- 53a0d27f-8fa9-4b03-a6c9-1f9573f0de9b
Device Description
Gates Glidden Drill #5 28MM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40529 | Rotary/reciprocating endodontic file/rasp, reusable | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D716GG5281 | HIBCC |