Shur-Strip® DKC81118
GUDID 00809958181218
Shur Strip Sterile Skin Closures
Derma Sciences Canada Inc
Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip| Primary Device ID | 00809958181218 |
| NIH Device Record Key | 90f6583a-92c8-4536-88cc-876949404549 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shur-Strip® |
| Version Model Number | 81118 |
| Catalog Number | DKC81118 |
| Company DUNS | 200564891 |
| Company Name | Derma Sciences Canada Inc |
| Device Count | 50 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
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 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00809958181201 [Unit of Use] |
| GS1 | 00809958181218 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K894205
FDA Product Code
| FPX | Strip, adhesive, closure, skin |
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 | 2018-11-23 |
| Device Publish Date | 2018-10-23 |
On-Brand Devices [Shur-Strip®]
| 00809958181515 | Shur Strip Sterile Skin Closures |
| 00809958181416 | Shur Strip Sterile Skin Closures |
| 00809958181218 | Shur Strip Sterile Skin Closures |
Trademark Results [Shur-Strip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHUR-STRIP 73233391 1156937 Dead/Cancelled |
Shur Medical Corporation 1979-10-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.