Home GUDID 00842071148942 GEMINI Suture Loop
Primary DI 00842071148942
Brand GEMINI Suture Loop
Company APPLIED MEDICAL TECHNOLOGY, INC.
Model ES4-8000
Catalog number ES4-8000, S4-8000
Device description 3-0 Braided Polyester Suture Loop with Magnet (Pouched)
Published 2025-04-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name GCJ Laparoscope, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842071148942 Package GS1 10 In Commercial Distribution 00842071148935 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842071148942 00842071148942 842071148942 0842071148942 00842071148935 00842071148935 842071148935 0842071148935
GMDN Terms# Term, Definition table Term Definition Polyester suture, non-bioabsorbable, multifilament A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.
Regulatory Flags# DUNS number 038101861 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00842071146436 MINI Balloon Button 5-1623 5-1623 2026-07-17 00842071146443 MINI Balloon Button 5-1623-I 5-1623-I 2026-07-17 00842071153083 NutraGlide Nasal Feeding Tube ENFT-05055-I ENFT-05055-I, NFT-05055-I 2026-06-10 00842071153106 NutraGlide Nasal Feeding Tube ENFT-05090-I ENFT-05090-I, NFT-05090-I 2026-06-10 00842071153120 NutraGlide Nasal Feeding Tube ENFT-06055-I ENFT-06055-I, NFT-06055-I 2026-06-10 00842071153144 AMT MiniONE Extension Set E8-2455-ISOSAF E8-2455-ISOSAF, 8-2455-ISOSAF 2026-05-13 00842071147198 MINI Balloon Button 5-2427 2026-05-07 00842071147204 MINI Balloon Button 5-2427-I 5-2427-I 2026-05-07 00842071153045 AMT MiniSPC Drainage Set ES1-1221 ES1-1221, S1-1221 2026-04-28 00842071153069 AMT MiniSPC Drainage Set ES1-2421 ES1-2421, S1-2421 2026-04-28 00842071146276 MINI Balloon Button 5-1455 5-1455 2026-04-09 00842071146283 MINI Balloon Button 5-1455-I 5-1455-I 2026-04-09 00842071148935 GEMINI Suture Loop ES4-8000 ES4-8000, S4-8000 2025-04-07 00842071151119 RHAPSO ESD110-S-07 ESD110-S-07, SD110-S-07-101, SD110-S-07-105 2026-03-25 00842071151140 RHAPSO ESD110-C-07 ESD110-C-07, SD110-C-07-101, SD110-C-07-105 2026-03-25 00842071153021 AMT MiniONE Extension Set E8-1255-ISOSAF E8-1255-ISOSAF, 8-1255-ISOSAF 2026-03-23 00842071153038 AMT MiniONE Extension Set E8-1255-ISOSAF E8-1255-ISOSAF, 8-1255-ISOSAF 2026-03-23 00842071150952 AMT MiniSPC Drainage Set ES1-1221 ES1-1221, S1-1221 2026-03-18 00842071150976 AMT MiniSPC Drainage Set ES1-2421 ES1-2421, S1-2421 2026-03-18 00842071152758 MiniSPC Button SPC-2425-12 SPC-2425-12 2026-03-18
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