AccessGUDID - DEVICE: PUMA-G System™ (10860312001532)

GUDID

Device Identifier (DI) Information

Brand Name: PUMA-G System™
Version or Model: 0010080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0010090
Company Name: Coaptech, Inc.

Primary DI Number: 10860312001532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080322442 *Terms of Use

Device Description: External Magnet in Case

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64056	Ultrasound-guided gastrostomy system magnet	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGC	Tube, Gastro-Enterostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store away from ferromagnetic material

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c55c5cf5-893c-408b-b7a7-710af56e45bf
Public Version Date: May 24, 2024
Public Version Number: 1
DI Record Publish Date: May 16, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860312001542	1	10860312001532		In Commercial Distribution	Shipper Box

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 00860312001535
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1 443 574 6934
Email: info@coaptech.com

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