FDA UDI
In Commercial Distribution
🇺🇸 United States
Caplugs/Evergreen
DI: 00810044204810
·
Model: 500
·
CAPlugs
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Caplugs/Evergreen
- Primary DI
- 00810044204810
- Version / Model
- 500
- Catalog Number
- 333-5005-U10
- Company Name
- CAPlugs
- Labeler DUNS
- 098203461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2021-12-08
- Public Version
- 1
- Public Version Date
- 2021-12-16
- Public Version Status
- New
- Public Device Record Key
- d3a50cbb-eafc-46a4-818c-9b39cbf6eaa8
Device Description
INNOC 5UL LOOP & ARROWHD
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LIB | DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15155 | Inoculating tool IVD, manual | A hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810044205091 | GS1 | ||||
| Primary | 00810044204810 | GS1 |
Customer Contacts
- Phone
- +1(716)876-9855 ext. 3241
- [email protected]