FDA UDI
In Commercial Distribution
🇺🇸 United States
Biogel Sensor®
DI: 05060097933730
·
Model: 30655
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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
- Biogel Sensor®
- Primary DI
- 05060097933730
- Version / Model
- 30655
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-21
- Public Version
- 4
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- 014bd0fb-4b76-4ad8-8f3e-89552e071d78
Device Description
Biogel Sensor 5.5 x 50 US
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 | 05060097933815 | GS1 | PACK_OR_INNER_PACK | 50 | In Commercial Distribution | |
| Primary | 05060097933730 | GS1 | ||||
| Package | 05060097933891 | GS1 | CASE | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071700 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5.5 |