AbsorbaTack ABSTACK10
GUDID 10613830159373
Fixation Device;10 Violet Absorbable Tacks
Covidien LP
Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler| Primary Device ID | 10613830159373 |
| NIH Device Record Key | 48943882-5033-4246-abb1-7468232e17d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AbsorbaTack |
| Version Model Number | ABSTACK10 |
| Catalog Number | ABSTACK10 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613830159376 [Primary] |
| GS1 | 10613830159373 [Package] Contains: 00613830159376 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091900
FDA Product Code
| GDW | STAPLE, IMPLANTABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-31 |
On-Brand Devices [AbsorbaTack]
| 10613830159380 | Fixation Device;20 Violet Absorbable Tacks |
| 10613830159373 | Fixation Device;10 Violet Absorbable Tacks |
| 20884523006152 | Fixation Device;20 Violet Absorbable Tacks |
Trademark Results [AbsorbaTack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABSORBATACK 77270838 3473531 Live/Registered |
COVIDIEN LP 2007-09-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.