FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrapac
DI: 05010058073951
·
Model: 7395
·
ROBINSON HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Instrapac
- Primary DI
- 05010058073951
- Version / Model
- 7395
- Catalog Number
- 7395
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-08
- Public Version
- 1
- Public Version Date
- 2023-08-16
- Public Version Status
- New
- Public Device Record Key
- 61e47a37-b54c-458f-9c22-17d9ad9102a9
Device Description
Instrapac Dental Luxation Instrument 3C (3mm Curved) x 10
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMJ | Elevator, Surgical, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45700 | Periotome, single-use | A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05010058173958 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 05010058073951 | GS1 |
Customer Contacts
- Phone
- +441909735502
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3mm curved |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry and keep out of direct sunlight