FDA UDI
In Commercial Distribution
🇺🇸 United States
MH
DI: 10850018327975
·
Model: 97-0250-AT
·
Mazza Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
64
Basic Information
- Brand Name
- MH
- Primary DI
- 10850018327975
- Version / Model
- 97-0250-AT
- Company Name
- Mazza Healthcare LLC
- Labeler DUNS
- 830069063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 64
- Record Status
- Published
- Publish Date
- 2024-10-25
- Public Version
- 2
- Public Version Date
- 2025-11-27
- Public Version Status
- Update
- Public Device Record Key
- 75d082b6-6afa-4b0d-87c9-8e9e093adf7b
Device Description
CSR Wrap Closure Tape, 2.5cm x 50m, non-sterile
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
- Yes
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. 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 | 20850018327972 | GS1 | ||||
| Primary | 10850018327975 | GS1 |