FDA.reportPublic FDA data

ETHICON

Primary DI
10705031005525
Brand
ETHICON
Company
ETHICON, LLC
Model
450G
Catalog number
450G
Device description
Retention Suture Bridge
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGSRETENTION DEVICE, SUTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031005529PackageGS112Not in Commercial Distribution
10705031005525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503100552930705031005529
1070503100552510705031005525

GMDN Terms#

Term, Definition table
TermDefinition
Suture retention deviceA device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031047990PDSPDP310HPDP310H2015-09-01
10705031048003PDSPDP311HPDP311H2015-09-01
10705031048058PDSPDP332HPDP332H2015-09-01
10705031048140PDSPDP352HPDP352H2015-09-01
10705031048157PDSPDP353HPDP353H2015-09-01
10705031048201PDSPDP371TPDP371T2015-09-01
10705031048218PDSPDP397HPDP397H2015-09-01
10705031048225PDSPDP398HPDP398H2015-09-01
10705031048331PDSPDP452HPDP452H2015-09-01
10705031048348PDSPDP463GPDP463G2015-09-01
10705031048362PDSPDP467HPDP467H2015-09-01
10705031048492PDSPDP534TPDP534T2015-09-01
10705031048508PDSPDP535HPDP535H2015-09-01
10705031048584PDSPDP695HPDP695H2015-09-01
10705031048683PDSPDP968HPDP968H2015-09-01
10705031048706PDSPDP970HPDP970H2015-09-01
10705031048737PDSPDPB316HPDPB316H2015-09-01
10705031048744PDSPDPB317HPDPB317H2015-09-01
10705031048751PDSPDPB332HPDPB332H2015-09-01
10705031048768PDSPDPB333HPDPB333H2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011629412V-CloseDRS Vascular, Inc.KGS2026-03-09
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
00850012846680SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007140LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00860007834233SUTUREGARD(R) Classic Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
00860007834240SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
10888277381766MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
10884450786199Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00860011629405Q-StopDRS Vascular, Inc.KGS2024-05-23
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
00630094199818Bioseal Inc.BIOSEALKGS2023-12-19
00630094199832Bioseal Inc.BIOSEALKGS2023-12-19
00630094199863Bioseal Inc.BIOSEALKGS2023-12-19
00630094199870Bioseal Inc.BIOSEALKGS2023-12-19
00630094199894Bioseal Inc.BIOSEALKGS2023-12-19
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
10630094199877Bioseal Inc.BIOSEALKGS2023-12-19
10630094199891Bioseal Inc.BIOSEALKGS2023-12-19
00630094199719Bioseal Inc.BIOSEALKGS2023-12-12
00630094199733Bioseal Inc.BIOSEALKGS2023-12-12
00630094199757Bioseal Inc.BIOSEALKGS2023-12-12
00630094199788Bioseal Inc.BIOSEALKGS2023-12-12