FDA.reportPublic FDA data

PUMA-G System™

Primary DI
00850026037234
Brand
PUMA-G System™
Company
Coaptech, Inc.
Model
0010416
Catalog number
0010470
Device description
Percutaneous Ultrasound Gastrostomy (PUG) SystemGuidewire with Pull Feature
Published
2024-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
00850026037210PackageGS12In Commercial Distribution
10850026037231PackageGS12In Commercial Distribution
00850026037234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026037210008500260372108500260372100850026037210
1085002603723110850026037231
00850026037234008500260372348500260372340850026037234

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
080322442
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00860312001542PUMA-G System™001008000100902024-05-16
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
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
00860312001542PUMA-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