SEPRAFILM 664201
GUDID 35413765589622
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
Surgical anti-adhesion material, implantable, bioabsorbable| Primary Device ID | 35413765589622 |
| NIH Device Record Key | 42aa024b-d8fc-47cf-8d42-37d41c994ad3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEPRAFILM |
| Version Model Number | 664201 |
| Catalog Number | 664201 |
| Company DUNS | 005083209 |
| Company Name | BAXTER HEALTHCARE CORPORATION |
| Device Count | 2 |
| DM Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
| Length | 3 Inch |
| Width | 5 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413765589621 [Primary] |
| GS1 | 35413765589622 [Package] Contains: 05413765589621 Package: PK [10 Units] In Commercial Distribution |
| GS1 | 75413765589620 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950034
FDA Product Code
| MCN | Barrier, absorbable, adhesion |
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 | 2021-06-18 |
| Device Publish Date | 2021-06-10 |
On-Brand Devices [SEPRAFILM]
| 35413765589653 | Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier |
| 35413765589646 | Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier |
| 35413765589639 | Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier |
| 35413765589622 | Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier |
| 35413765589615 | Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier |
Trademark Results [SEPRAFILM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEPRAFILM 75894972 2511164 Live/Registered |
Genzyme Corporation 2000-01-11 |
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