Biogel Eclipse®
GUDID 05060097930661
Biogel Eclipse 6.5 x50 US
Mölnlycke Health Care AB
Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial| Primary Device ID | 05060097930661 |
| NIH Device Record Key | 7248a20f-64f1-4e47-b535-6ad649a22c82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biogel Eclipse® |
| Version Model Number | 75265 |
| 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 |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060097930500 [Primary] |
| GS1 | 05060097930586 [Package] Contains: 05060097930500 Package: PACK_OR_INNER_PACK [50 Units] In Commercial Distribution |
| GS1 | 05060097930661 [Package] Contains: 05060097930586 Package: CASE [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K053443
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 Eclipse®]
| 05060097930715 | Biogel Eclipse 9.0 x40 US |
| 05060097930708 | Biogel Eclipse 8.5 x50 US |
| 05060097930692 | Biogel Eclipse 8.0 x50 US |
| 05060097930685 | Biogel Eclipse 7.5 x50 US |
| 05060097930678 | Biogel Eclipse 7.0 x50 US |
| 05060097930661 | Biogel Eclipse 6.5 x50 US |
| 05060097930654 | Biogel Eclipse 6.0 x50 US |
| 05060097930562 | Biogel Eclipse 5.5 x50 US |
Trademark Results [Biogel Eclipse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOGEL ECLIPSE 78534254 3357132 Live/Registered |
Regent Medical Limited 2004-12-17 |
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