FDA UDI
In Commercial Distribution
🇺🇸 United States
Keystone Industries
DI: H66819007701
·
Model: 1900770
·
Keystone Industries
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Keystone Industries
- Primary DI
- H66819007701
- Version / Model
- 1900770
- Catalog Number
- 1900770
- Company Name
- Keystone Industries
- Labeler DUNS
- 073503117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 678abcc1-61a8-47f9-a126-80967cea016f
Device Description
Pkg/10x1 Ft Clasp Wire 18Ga Rd
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJW | CLASP, WIRE | Dental | 872.3285 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42879 | Denture clasp, metal, custom-made | A dental device made of metal, typically in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet the specifications of an individual patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | H66819007700 | HIBCC | ||||
| Primary | H66819007701 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1 | Millimeter |