PUMA-G Pediatric System™ 0010405

GUDID 20850026037177

80% Offset External Magnet in Case

Coaptech, Inc.

Ultrasound-guided gastrostomy system magnet
Primary Device ID20850026037177
NIH Device Record Keya50271b8-e57f-4a1a-8de8-f9d49abba261
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUMA-G Pediatric System™
Version Model Number0010400
Catalog Number0010405
Company DUNS080322442
Company NameCoaptech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com
Phone1-443-574-6934
Emailinfo@coaptech.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026037173 [Direct Marking]
GS110850026037170 [Primary]
GS120850026037177 [Package]
Contains: 10850026037170
Package: Shipper Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGCTube, Gastro-Enterostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-31
Device Publish Date2025-12-23

On-Brand Devices [PUMA-G Pediatric System™]

2085002603717780% Offset External Magnet in Case
10850026037200Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit

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