DEVICE: ONETRAC (M648C1001100)
Device Identifier (DI) Information
ONETRAC
C100110
In Commercial Distribution
C100110
OBP CORPORATION
C100110
In Commercial Distribution
C100110
OBP CORPORATION
Retractor 135X30mm with Built-In Single-Use Light Source - STERILE
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 13375 | Abdominal retractor, hand-held |
A surgical instrument designed to be held by the surgeon or assistant to separate the margins of an abdominal incision, typically during deep surgery, to expose or access organs or tissues for examination or intervention. The instrument consists of a blunt-edged, non-adjustable flat blade that curves near the distal tip, with a solid handle at the proximal end. The surgeon or assistant uses this instrument to manually pull the edge of the incision open. It is made of high-grade stainless steel and is available in a variety of blade lengths. This is a reusable device intended to be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GAD | Retractor |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 5 and 35 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
b210f573-697c-40f4-918a-b7bb50b46dfc
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| M648C1001102 | 4 | M648C1001101 | In Commercial Distribution | CASE | |
| M648C1001101 | 10 | M648C1001100 | In Commercial Distribution | BOX |
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