Biogel PI Pro-Fit®
GUDID 07332551976828
Biogel PI Pro-Fit 8.5x50
Mölnlycke Health Care AB
Polyisoprene surgical glove, non-powdered, non-antimicrobial| Primary Device ID | 07332551976828 |
| NIH Device Record Key | 194137cc-1ec6-4d49-bbc4-45411567b40f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biogel PI Pro-Fit® |
| Version Model Number | 47985 |
| 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 | false |
| 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 |
| 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 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 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 Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332551976828 [Package] Contains: 07332551976835 Package: CASE [4 Units] In Commercial Distribution |
| GS1 | 07332551976835 [Package] Contains: 07332551976842 Package: PACK_OR_INNER_PACK [50 Units] In Commercial Distribution |
| GS1 | 07332551976842 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050184
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 PI Pro-Fit®]
| 07332551976903 | Biogel PI Pro-Fit 9.0x40 |
| 07332551976828 | Biogel PI Pro-Fit 8.5x50 |
| 07332551976750 | Biogel PI Pro-Fit 8.0x50 |
| 07332551976682 | Biogel PI Pro-Fit 7.5x50 |
| 07332551976613 | Biogel PI Pro-Fit 7.0x50 |
| 07332551976545 | Biogel PI Pro-Fit 6.5x50 |
| 07332551976477 | Biogel PI Pro-Fit 6.0x50 |
Trademark Results [Biogel PI Pro-Fit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOGEL PI PRO-FIT 85314388 4500138 Live/Registered |
Mölnlycke Health Care AB 2011-05-06 |
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