FDA UDI
In Commercial Distribution
🇺🇸 United States
PELLO
DI: 07613327579055
·
Model: 629051214070
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PELLO
- Primary DI
- 07613327579055
- Version / Model
- 629051214070
- Catalog Number
- 6290-512-140-70
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-13
- Public Version
- 2
- Public Version Date
- 2025-02-13
- Public Version Status
- Update
- Public Device Record Key
- 15a355d4-5e3c-48b2-97cb-57738b3f5660
Device Description
4mm Angled 70 Degree Diamond Bur
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EQJ | BUR, EAR, NOSE AND THROAT | Ear, Nose, Throat | 874.4140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45527 | Diamond ENT bur, single-use | A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327579055 | GS1 |
Customer Contacts
- Phone
- +0118002533210
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 27 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity