Biogel Sensor®
GUDID 05060097932542
Biogel Super Sensitive 6.5x50 US EUR
Mölnlycke Health Care AB
Hevea-latex surgical glove, non-powdered, non-antimicrobial| Primary Device ID | 05060097932542 |
| NIH Device Record Key | 49467495-c239-436f-aaa0-6f6bbbf0488c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biogel Sensor® |
| Version Model Number | 82565 |
| Company DUNS | 631770658 |
| Company Name | Mölnlycke Health Care AB |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060097932382 [Primary] |
| GS1 | 05060097932467 [Package] Contains: 05060097932382 Package: PACK_OR_INNER_PACK [50 Units] In Commercial Distribution |
| GS1 | 05060097932542 [Package] Contains: 05060097932467 Package: CASE [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071700
FDA Product Code
| KGO | Surgeon's gloves |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
On-Brand Devices [Biogel Sensor®]
| 05060097933969 | Biogel Sensor 9.0 x 40 US |
| 05060097933877 | Biogel Sensor 8.5 x 50 US |
| 05060097933945 | Biogel Sensor 8.0 x 50 US |
| 05060097933853 | Biogel Sensor 7.5 x 50 US |
| 05060097933846 | Biogel Sensor 7.0 x 50 US |
| 05060097933914 | Biogel Sensor 6.5 x 50 US |
| 05060097933907 | Biogel Sensor 6.0 x 50 US |
| 05060097933815 | Biogel Sensor 5.5 x 50 US |
| 05060097932511 | Biogel Super Sensitive 9.0x40 US EUR |
| 05060097932504 | Biogel Super Sensitive 8.5x50 US EUR |
| 05060097932498 | Biogel Super Sensitive 8.0x50 US EUR |
| 05060097932481 | Biogel Super Sensitive 7.5x50 US EUR |
| 05060097932474 | Biogel Super Sensitive 7.0x50 US EUR |
| 05060097932542 | Biogel Super Sensitive 6.5x50 US EUR |
| 05060097932535 | Biogel Super Sensitive 6.0x50 US EUR |
| 05060097932528 | Biogel Super Sensitive 5.5x50 US EUR |
Trademark Results [Biogel Sensor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOGEL SENSOR 74408371 1922868 Live/Registered |
REGENT MEDICAL LIMITED 1993-07-02 |
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