FDA.reportPublic FDA data

PUMA-G System™

Primary DI
00860312001542
Brand
PUMA-G System™
Company
Coaptech, Inc.
Model
0010080
Catalog number
0010090
Device description
External Magnet in Case
Published
2024-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGCTube, Gastro-Enterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGCTube, Gastro-EnterostomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860312001535Direct MarkingGS10
00860312001542PackageGS11In Commercial Distribution
10860312001532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860312001535008603120015358603120015350860312001535
00860312001542008603120015428603120015420860312001542
1086031200153210860312001532

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound-guided gastrostomy system magnetA hand-held device intended to be placed non-invasively on the anterior abdominal wall to attract the stomach wall via a magnet at the distal end of an in situ ultrasound-guided gastrostomy system catheter (not included), to facilitate a gastrostomy. The optimal placement of the catheter tip without intervention of other anatomical structures (e.g., organs, vessels) is achieved using an ultrasound imaging system (not included). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from ferromagnetic material

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 443 574 6934info@coaptech.com

Regulatory Flags#

DUNS number
080322442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860312001532PUMA-G System™001008000100902024-05-16
00850026037029PUMA-G System™001020400102122023-12-15
00850026037043PUMA-G System™001021000102182023-07-13
00850026037050PUMA-G System™001020800102162023-12-15
00860312001504PUMA-G System™001004000103592023-07-13
00850026037036PUMA-G System™001020600102142023-07-13
10850026037170PUMA-G Pediatric System™001040000104052025-12-23
00850026037203PUMA-G Pediatric System™001038000103812025-12-23
10850026037200PUMA-G Pediatric System™001038000103812025-12-23
20850026037177PUMA-G Pediatric System™001040000104052025-12-23
00850026037234PUMA-G System™001041600104702024-10-29
00860312001559PUMA-G System™001004600101702024-10-29
10850026037231PUMA-G System™001041600104702024-10-29
10860312001556PUMA-G System™001004600101702024-10-29
00850026037227PUMA-G System™00104400010450-0X, 00104602024-02-13
00850026037333PUMA-G System™00104450010445-042024-05-16
10850026037330PUMA-G System™00104450010445-042024-05-16
00850026037319PUMA-G System™001048000104802024-05-09
10850026037132PUMA-G System™001032300103662023-07-13
00850026037272PUMA-G System™00104500010450-0X, 00104602024-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850026037170PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00850026037203PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
10850026037200PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
20850026037177PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00842071148935GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-04-07
00842071148973GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071149000GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071147297GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-11-27
00850026037234PUMA-G System™Coaptech, Inc.KGC2024-10-29
00860312001559PUMA-G System™Coaptech, Inc.KGC2024-10-29
10850026037231PUMA-G System™Coaptech, Inc.KGC2024-10-29
10860312001556PUMA-G System™Coaptech, Inc.KGC2024-10-29
00842071144968GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
00842071144999GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
10860312001532PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037333PUMA-G System™Coaptech, Inc.KGC2024-05-16
10850026037330PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037319PUMA-G System™Coaptech, Inc.KGC2024-05-09
00850026037227PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037272PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037029PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037050PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037098PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037074PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037043PUMA-G System™Coaptech, Inc.KGC2023-07-13
00860312001504PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037036PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037081PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037187PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037132PUMA-G System™Coaptech, Inc.KGC2023-07-13