FDA UDI
In Commercial Distribution
🇺🇸 United States
GC Plastic Syringe
DI: 10386040006286
·
Model: 159300
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- GC Plastic Syringe
- Primary DI
- 10386040006286
- Version / Model
- 159300
- Catalog Number
- 159300
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-07-07
- Public Version
- 1
- Public Version Date
- 2022-07-15
- Public Version Status
- New
- Public Device Record Key
- e78f830e-b361-4706-8700-3f0c9479574c
Device Description
GC Plastic Syringe Tips, Package of 100
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55894 | Haemoglobin E (HbE) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype E (HbE) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00386040006289 | GS1 | ||||
| Primary | 10386040006286 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]