FDA UDI
In Commercial Distribution
🇺🇸 United States
Alligator
DI: 00836462014015
·
Model: FA-88810-20
·
Micro Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alligator
- Primary DI
- 00836462014015
- Version / Model
- FA-88810-20
- Catalog Number
- FA-88810-20
- Company Name
- Micro Therapeutics, Inc.
- Labeler DUNS
- 826110710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-12
- Public Version
- 3
- Public Version Date
- 2020-06-05
- Public Version Status
- Update
- Public Device Record Key
- 5aa227ca-adc3-4942-9ff5-c592472fa432
Device Description
Retrieval Device
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
- No
- 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 |
|---|---|---|---|---|
| DQY | CATHETER, PERCUTANEOUS | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46219 | Medical device adhesive | A substance primarily intended to promote the bonding of two surfaces in the manufacture of medical devices (e.g., active implantable devices). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00836462014015 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT