DEVICE: SOFIA VITALITEC (03661522040119)
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If so, send a picture of the label to
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Device Identifier (DI) Information
SOFIA VITALITEC
VSL-1807
In Commercial Distribution
VSL-1807
PETERS SURGICAL
VSL-1807
In Commercial Distribution
VSL-1807
PETERS SURGICAL
Atraumatic Spring Clip 1/2 FORCE
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 62480 | Surgical bulldog clamp, single-use |
A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DXC | Clamp, Vascular |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store the unopened sterile pack in a cool, dry, well-ventilated place away from extremes of temperature or humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Jaw opening = 7 mm |
Device Record Status
097ae9a8-8af4-44be-b46b-caeb254ec7f0
July 12, 2023
4
July 31, 2019
July 12, 2023
4
July 31, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 13661522040116 | 12 | 03661522040119 | In Commercial Distribution |
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
[?]
+1 508-747-6033
e.knupp@peters-surgical.com
e.knupp@peters-surgical.com