FDA UDI
In Commercial Distribution
🇺🇸 United States
Trustex Strawberry
DI: 00726893112384
·
Model: L4015
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
3
Basic Information
- Brand Name
- Trustex Strawberry
- Primary DI
- 00726893112384
- Version / Model
- L4015
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-06-12
- Public Version
- 2
- Public Version Date
- 2023-08-09
- Public Version Status
- Update
- Public Device Record Key
- d4e27977-8341-42e8-b9de-755a35c85a2c
Device Description
3 Lubricated Male Late Condoms
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIS | Condom | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45138 | Basic male condom, Hevea-latex | A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10726893112381 | GS1 | Bundle of 12, 3 pks. | 12 | In Commercial Distribution | |
| Primary | 00726893112384 | GS1 | ||||
| Unit of Use | 80726893112380 | GS1 | ||||
| Package | 20726893112388 | GS1 | Case of 72, 3 pks. | 72 | In Commercial Distribution |