FDA UDI
In Commercial Distribution
🇺🇸 United States
Misc
DI: 00889989061468
·
Model: 740-0042
·
ORMCO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Misc
- Primary DI
- 00889989061468
- Version / Model
- 740-0042
- Company Name
- ORMCO CORPORATION
- Labeler DUNS
- 154614119
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-07
- Public Version
- 1
- Public Version Date
- 2024-03-15
- Public Version Status
- New
- Public Device Record Key
- fb80a1e0-2060-4885-9a76-78ada1bbe50f
Device Description
SPATULA DISPOSABLE PK 75
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
- Yes
- 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 |
|---|---|---|---|---|
| KXR | APPLICATOR, RESIN | Dental | 872.3140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35697 | Dental material application tool, single-use | A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889989061468 | GS1 |
Customer Contacts
- Phone
- +18008541741
- [email protected]