FDA UDI
In Commercial Distribution
🇺🇸 United States
Infinity
DI: 20845854083472
·
Model: KRR065
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Infinity
- Primary DI
- 20845854083472
- Version / Model
- KRR065
- Catalog Number
- KRR065
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-21
- Public Version
- 2
- Public Version Date
- 2023-02-15
- Public Version Status
- Update
- Public Device Record Key
- 157f13bb-37c0-4d11-bd20-d99e647da0c5
Device Description
Infinity Retro-Reamer 6.5mm
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
- Yes
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFG | BIT, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43390 | Fluted surgical drill bit, single-use | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20845854083472 | GS1 | ||||
| Previous | 20845854901950 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.5 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY