DEVICE: TAPES (05425029282094)
Device Identifier (DI) Information
Device Characteristics
| MR Safe | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 57874 | Suturing unit, single-use |
A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| OCW | Endoscopic Tissue Approximation Device |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K211309 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
74cfbcc9-1961-46ea-b1be-3e26d7375414
October 28, 2024
4
July 19, 2022
October 28, 2024
4
July 19, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 05425029282698 | 6 | 05425029282094 | In Commercial Distribution | secondary packaging | |
| 05425029282391 | 12 | 05425029282094 | In Commercial Distribution | Tertiary packaging | |
| 05425029282995 | 288 | 05425029282094 | In Commercial Distribution | Pallet | |
| 05425029282919 | 96 | 05425029282094 | In Commercial Distribution | Pallet | |
| 05425029282988 | 144 | 05425029282094 | In Commercial Distribution | Pallet | |
| 05425029282933 | 192 | 05425029282094 | In Commercial Distribution | Pallet | |
| 05425029282964 | 240 | 05425029282094 | In Commercial Distribution | Pallet |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined