BIOBRANE 66027706
GUDID 05000223504175
BIOBRANE DRESSING - LARGE GLOVE US
SMITH & NEPHEW MEDICAL LIMITED
Collagen wound matrix dressing| Primary Device ID | 05000223504175 |
| NIH Device Record Key | 09194071-32fd-4727-9553-59db6397de03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOBRANE |
| Version Model Number | 66027706 |
| Catalog Number | 66027706 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
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| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05000223504090 [Primary] |
| GS1 | 05000223504175 [Package] Contains: 05000223504090 Package: CAR [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K242146
FDA Product Code
| KGN | Wound dressing with animal-derived material(s) |
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 | 2025-03-11 |
| Device Publish Date | 2025-03-03 |
On-Brand Devices [BIOBRANE]
| 05000223504120 | BIOBRANE DRESSING 5.1INX15IN CTN 5 (US) |
| 05000223504144 | BIOBRANE DRESSING 15INX19.7IN CTN 1 US |
| 05000223504137 | BIOBRANE DRESSING 9.8INX15IN CTN 1 US |
| 05000223504113 | BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US |
| 05000223504182 | BIOBRANE DRESSING - PEDIATRIC GLOVE US |
| 05000223504175 | BIOBRANE DRESSING - LARGE GLOVE US |
| 05000223504168 | BIOBRANE DRESSING - MEDIUM GLOVE US |
| 05000223504151 | BIOBRANE DRESSING - SMALL GLOVE US |
Trademark Results [BIOBRANE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOBRANE 97753127 not registered Live/Pending |
Smith & Nephew, Inc. 2023-01-13 |
 BIOBRANE 73206968 1135459 Live/Registered |
WOODROOF LABORATORIES, INC. 1979-03-12 |
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