FDA UDI
In Commercial Distribution
🇺🇸 United States
TopCare Health
DI: 00036800022683
·
Model: TOP4045V2
·
Topco Associates, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- TopCare Health
- Primary DI
- 00036800022683
- Version / Model
- TOP4045V2
- Catalog Number
- TOP4045V2
- Company Name
- Topco Associates, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-01-27
- Public Version
- 1
- Public Version Date
- 2026-02-04
- Public Version Status
- New
- Public Device Record Key
- 0b6ac85e-91f3-4c32-9359-f8472764f566
Device Description
GLOVE, EXAM, NITRILE, PF, LF, 50CT, OSFM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36961 | Water jet knife system generator | A mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80368000226834 | GS1 | ||||
| Primary | 00036800022683 | GS1 | ||||
| Package | 10036800022680 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Package | 20368000226832 | GS1 | Case | 4 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from freezing. Avoid excessive heat. Keep dry. Products should be shielded from direct sunlight, fluorescent lighting, x-rays, moisture and ozone