Product Code: GAT


Products Classified as GAT

5602Suture, Nonabsorbable, Synthetic, PolyethyleneNonabsorbable Poly(ethylene Terephthalate) Surgical Suture.

Total Product Life Cycle (TPLC) Devices

5602Suture, Nonabsorbable, Synthetic, PolyethyleneNonabsorbable Poly(ethylene Terephthalate) Surgical Suture.

FDA Consensus Standards

Suture, Nonabsorbable, Synthetic, Polyethylene [38449]21 CFR §878.5000 🔎
Suture, Nonabsorbable, Synthetic, Polyethylene [38450]21 CFR §878.5000 🔎
Suture, Nonabsorbable, Synthetic, Polyethylene [38448]21 CFR §878.5000 🔎
Suture, Nonabsorbable, Synthetic, Polyethylene [38451]21 CFR §878.5000 🔎

Pre-market Approvals for GAT

P810028DEKLENE(TM)DEKNATEL, INC.

Pre-market Notifications for GAT

K222078Arthrex SoftStitchArthrex, Inc
K221354Arthrex SutureTapeArthrex Inc.
K220880Arthrex BioSutureArthrex Inc.
K220219PERMALOOP Suture, PERMATAPE SutureMedos International SARL
K220186Zone Specific AIMCONMED Corporation
K203393FAST-FIX FLEXSmith & Nephew, Inc.
K203186DYNATAPE SutureMedos International SARL
K202242HS FiberRiverpoint Medical, LLC
K193575Arthrex SutureTapeArthrex Inc.
K192637High Strength SutureYunyi (Beijing) Medical Device Co., LTD
K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical
K191268Force Fiber SutureTeleflex Medical Incorporated
K190817HS FiberRiverpoint Medical
K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemeTECH Corporation
K190707Arthrex SoftStitchArthrex Inc.

Global Unique Device Identification Database

20386120007858Suture, Nonabsorbable, Synthetic, Polyethylene
20386120006325Suture, Nonabsorbable, Synthetic, Polyethylene
20386120006318Suture, Nonabsorbable, Synthetic, Polyethylene
20386120005663Suture, Nonabsorbable, Synthetic, Polyethylene
20304040000230SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
00685447000501Suture, Nonabsorbable, Synthetic, Polyethylene
10685447000492Suture, Nonabsorbable, Synthetic, Polyethylene
00685447000488Suture, Nonabsorbable, Synthetic, Polyethylene
10685447000478Suture, Nonabsorbable, Synthetic, Polyethylene
00685447000464Suture, Nonabsorbable, Synthetic, Polyethylene
10685447000454Suture, Nonabsorbable, Synthetic, Polyethylene
00685447000440Suture, Nonabsorbable, Synthetic, Polyethylene
10685447000430Suture, Nonabsorbable, Synthetic, Polyethylene
00685447000426Suture, Nonabsorbable, Synthetic, Polyethylene
10685447000416Suture, Nonabsorbable, Synthetic, Polyethylene

Maude Adverse Events

FAST-FIX 360 CURVED NDL DLVRY SYS EISMITH & NEPHEW, INC.2020-03-31
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-31
TI-CRONCOVIDIEN LP LLC NORTH HAVEN2020-03-31
EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGTETHICON INC.2020-03-30
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-30
ULTRA FAST-FIX ASSEMBLY - CURVEDSMITH & NEPHEW, INC.2020-03-30
ULTRA FAST-FIX AB ASSEMBLY - CURVEDSMITH & NEPHEW, INC.2020-03-30
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-30
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-30
V-LOCCOVIDIEN LP LLC NORTH HAVEN2020-03-30
ULTRA FAST-FIXSMITH & NEPHEW, INC. ENDOSCOPY DIVISION2020-03-30
ULTRA FAST-FIX ASSEMBLY - CURVEDSMITH & NEPHEW, INC.2020-03-29
ETHIBOND EXCEL WHI 45CM M1.5ETHICON INC.2020-03-27
AIR MENISCUS SYSTEM, CURVEDSTRYKER ENDOSCOPY-SAN JOSE2020-03-27
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-26
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-26
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-26
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-26
MERSILENE GRN 75CM M4::USP1 SGLE ARMED CP-2ETHICON INC.2020-03-25
ETHICON MESH UNKNOWNETHICON INC.2020-03-25
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-25
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-24
TI-CRONDAVIS & GECK CARIBE LTD2020-03-24
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-23
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-23
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-23
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-23
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-23
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-23
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-20
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-19
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-18
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-18
ETHIBOND EXCEL WHI 90CM M3ETHICON INC.2020-03-18
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-18
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-18
MERS WHT 18IN 5-0 D/A RV-2ETHICON INC.2020-03-18
MERS WHT 18IN 5-0 D/A RV-2ETHICON INC.2020-03-18
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-17
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-17
FAST-FIX 360 CURVED NDL DELIVERY SYSSMITH & NEPHEW, INC.2020-03-17
COTTONY II DACRON, SILKY II, POLYDEK&TEVDEK ITELEFLEX MEDICAL2020-03-17
COTTONY II DACRON, SILKY II, POLYDEK&TEVDEK ITELEFLEX MEDICAL2020-03-17
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-17
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-17
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-17
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-17
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-17
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWNETHICON INC.2020-03-17
ETHICON MESH UNKNOWNETHICON INC.2020-03-16

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