FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Triumph
DI: 10818634022650
·
Model: 71-ME2360
·
Bosma Enterprises
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Triumph
- Primary DI
- 10818634022650
- Version / Model
- 71-ME2360
- Catalog Number
- 71-ME2360
- Company Name
- Bosma Enterprises
- Labeler DUNS
- 878070325
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-07-01
- Public Version
- 3
- Public Version Date
- 2024-04-01
- Public Version Status
- Update
- Public Device Record Key
- debbfab7-a441-449d-9a67-9cac88428e90
- Distribution End Date
- 2024-03-31
Device Description
Triumph Micro Latex Surgical 6.0 - 50 Pair/Box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGO | Surgeon'S Gloves | General, Plastic Surgery | 878.4460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47178 | Hevea-latex surgical glove, non-powdered, non-antimicrobial | A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20818634022657 | GS1 | Case | 4 | Not in Commercial Distribution | 2024-03-31 |
| Primary | 10818634022650 | GS1 | ||||
| Unit of Use | 00818634022653 | GS1 |
Customer Contacts
- Phone
- 800-362-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture, and ozone.