RHAPSO ESD110-C-07, SD110-C-07-101, SD110-C-07-105

GUDID 00842071149437

RHAPSO Suture Passer (Curved Needle, Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Suturing unit, single-use
Primary Device ID00842071149437
NIH Device Record Key3cbf3d68-4342-41e3-a9c4-e8dd5d828cf0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRHAPSO
Version Model NumberESD110-C-07
Catalog NumberESD110-C-07, SD110-C-07-101, SD110-C-07-105
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071149420 [Primary]
GS100842071149437 [Package]
Contains: 00842071149420
Package: Box (SD110-C-07-101) [1 Units]
In Commercial Distribution
GS100842071149444 [Package]
Contains: 00842071149420
Package: Box (SD110-C-07-105) [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-14
Device Publish Date2025-05-06

On-Brand Devices [RHAPSO]

00842071149437RHAPSO Suture Passer (Curved Needle, Pouched)
00842071149406RHAPSO Suture Passer (Straight Needle, Pouched)

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