FDA UDI
In Commercial Distribution
🇺🇸 United States
Caplugs/Evergreen
DI: 00810044208047
·
Model: 222-8600-01A
·
CAPlugs
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Caplugs/Evergreen
- Primary DI
- 00810044208047
- Version / Model
- 222-8600-01A
- Catalog Number
- 222-8600-01A
- Company Name
- CAPlugs
- Labeler DUNS
- 098203461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 1
- Public Version Date
- 2024-06-10
- Public Version Status
- New
- Public Device Record Key
- a55c28f9-9225-46e2-93ee-d760d06daed7
Device Description
95 PIN INOCULATOR ASSEMBLY
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 |
|---|---|---|---|---|
| JTC | DEVICE, MICROTITER DILUTING/DISPENSING | Microbiology | 866.2500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63707 | Inoculating tool IVD, analyser/instrument | A component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810044208252 | GS1 | ||||
| Primary | 00810044208047 | GS1 |
Customer Contacts
- Phone
- +1(716)876-9855 ext. 3241
- [email protected]