ApeLoop

GUDID 00840277409614

White/Black UHMWPE Polyblend Non-Absorbable Split-Stitch Suture

RIVERPOINT MEDICAL, LLC

Polyolefin/fluoropolymer suture, multifilament
Primary Device ID00840277409614
NIH Device Record Key77062a13-f9ac-4dda-b580-006c1eaa6ff5
Commercial Distribution StatusIn Commercial Distribution
Brand NameApeLoop
Version Model NumberP64-40W-2020-01
Company DUNS964053560
Company NameRIVERPOINT MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840277409614 [Primary]

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

On-Brand Devices [ApeLoop]

00840277409614White/Black UHMWPE Polyblend Non-Absorbable Split-Stitch Suture
00840277409607White/Black UHMWPE Polyblend Non-Absorbable Split-Stitch Suture
00840277409591White/Black UHMWPE Polyblend Non-Absorbable Split-Stitch Suture
00840277409584White/Black UHMWPE Polyblend Non-Absorbable Split-Stitch Suture

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.