FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFESTYLES
DI: 08859798106058
·
Model: 08859798106058
·
SURETEX LIMITED - BRANCH
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
37
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Basic Information
- Brand Name
- LIFESTYLES
- Primary DI
- 08859798106058
- Version / Model
- 08859798106058
- Company Name
- SURETEX LIMITED - BRANCH
- Labeler DUNS
- 672044515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 37
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 1
- Public Version Date
- 2025-06-26
- Public Version Status
- New
- Public Device Record Key
- cca0cc8e-e93c-4a6d-aedb-f946061253bc
Device Description
LifeStyles Pleasure Collection Latex Condom BX36 + Lube
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
| 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 |
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 28859798106052 | GS1 | ||||
| Primary | 08859798106058 | GS1 |