FDA UDI
In Commercial Distribution
🇺🇸 United States
Corning®
DI: H1084314181
·
Model: 431418
·
Corning Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Corning®
- Primary DI
- H1084314181
- Version / Model
- 431418
- Catalog Number
- 431418
- Company Name
- Corning Incorporated
- Labeler DUNS
- 001307735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-12-02
- Public Version
- 3
- Public Version Date
- 2022-03-23
- Public Version Status
- Update
- Public Device Record Key
- c31f0afa-7c84-479a-8b97-fa3f944edcd4
Device Description
Corning 2mL Blue Cap Internal Threaded Polypropylene Cryogenic Vial, Self-Standing with Round Bottom
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H1084314183 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | H1084314181 | HIBCC | ||||
| Unit of Use | H1084314180 | HIBCC |
Customer Contacts
- Phone
- +1(800)492-1110
- [email protected]