FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CellTram® Air
DI: 04043758000119
·
Model: 5176000068
·
Eppendorf AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CellTram® Air
- Primary DI
- 04043758000119
- Version / Model
- 5176000068
- Catalog Number
- 5176000068
- Company Name
- Eppendorf AG
- Labeler DUNS
- 315019588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-11
- Public Version
- 5
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 60efc578-7241-4cae-b4d4-1944ac6ad3f6
- Distribution End Date
- 2018-11-09
Device Description
Assisted Reproduction Microinjector
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 |
|---|---|---|---|---|
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | Obstetrics/Gynecology | 884.6150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34169 | Assisted reproduction electromechanical micromanipulator | An electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [e.g., intracytoplasmic sperm injection] usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04043758000119 | GS1 |