DEVICE: TROCAR INTRODUCER FOR LTF 5 MM SCOPE (04953170316159)
Device Identifier (DI) Information
TROCAR INTRODUCER FOR LTF 5 MM SCOPE
MAJ-1379
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1379
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1379 TROCAR INTRODUCER FOR LTF 5MM S
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
37142 | Endoscopic-access dilator, reusable |
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCJ | Laparoscope, general & plastic surgery |
HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
NWB | Endoscope, Accessories, Narrow Band Spectrum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K201832 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Moist Heat or Steam Sterilization |
Ethylene Oxide |
High-level Disinfectant |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c714837c-0144-42eb-af10-1e9d6ca01fd6
April 22, 2024
9
September 21, 2016
April 22, 2024
9
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 |
---|---|---|---|---|---|
No Package DIs found |
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(800)401-1086
xx@xx.xx
xx@xx.xx