FDA UDI
In Commercial Distribution
🇺🇸 United States
Celeris
DI: 00821925044944
·
Model: DSDPP100
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Celeris
- Primary DI
- 00821925044944
- Version / Model
- DSDPP100
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-10
- Public Version
- 3
- Public Version Date
- 2024-02-15
- Public Version Status
- Update
- Public Device Record Key
- 24f73f4e-eb77-436b-a0db-1bbf810529a0
Device Description
REUSABLE POWER PACK CELERIS
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36865 | Arthroscopic shaver system handpiece, pneumatic | A handle with attached cutting blade that is a component of a pneumatically-powered shaver system designed for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925044944 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212650 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity