FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Pre-calibrated Suction Charr. 8
DI: 04056481141165
·
Model: 52184-01
·
Brainlab AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Pre-calibrated Suction Charr. 8
- Primary DI
- 04056481141165
- Version / Model
- 52184-01
- Catalog Number
- 52184-01
- Company Name
- Brainlab AG
- Labeler DUNS
- 314482980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 2
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- c162ef86-3d34-4087-8d62-506f3a897093
Device Description
Disposable suction 2.7 mm
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64934 | Optical surgical navigation device tracking system suction cannula | An atraumatic, invasive, hand-operated, rigid/semi-rigid tubular component of an optical surgical navigation device tracking system designed as a conduit for aspiration of body cavities or surgical sites to facilitate observation and/or to clear airway obstruction, typically during a cranial and/or ENT procedure, in association with computer assisted surgery (CAS); it is not intended for surgical irrigation. Also referred to as a suction tube or tip, it incorporates a handle with features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera [e.g., infrared (IR) light camera]; it does not include a light source or fibreoptic bundle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056481141165 | GS1 | ||||
| Package | 04056481141158 | GS1 | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201752 | 000 |