Refill Tray 50

GUDID B875500

Convenience kit no Lidocaine

Custom Interventional Pain Management, LLC

Intrathecal anaesthesia set, non-medicated
Primary Device IDB875500
NIH Device Record Key09bbdcf7-0c4f-4916-bf85-b1290d281504
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefill Tray
Version Model Number50
Catalog Number50
Company DUNS030406006
Company NameCustom Interventional Pain Management, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB875500 [Primary]

FDA Product Code

OGEEpidural Anesthesia Kit

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


[B875500]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

Devices Manufactured by Custom Interventional Pain Management, LLC

B875700 - Individual Ancillary Item Kit2023-09-19 Convenience kit non-medicated
B87560LID0 - Discseel2023-08-23 Convenience kit with Lidocaine
B875DSCLID0 - Discseel2023-08-23 Convenience kit with Lidocaine
B875170 - Epidural Anesthesia Kit2023-07-27 Convenience kit no Lidocaine
B87517LID0 - Epidural Anesthesia Kit2023-07-27 Convenience kit with Lidocaine
B875180 - Epidural Anesthesia Kit2023-07-27 Convenience kit no Lidocaine
B87518LID0 - Epidural Anesthesia Kit2023-07-27 Convenience kit with Lidocaine
B875200 - Epidural Anesthesia Kit2023-07-27 Convenience kit no Lidocaine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.