FDA.report

ETHICON

Primary DI
30705031005529
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGSRETENTION DEVICE, SUTURE

Product Code Classifications

CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30705031005529PackageGS112In Commercial Distribution
10705031005525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070503100552930705031005529
1070503100552510705031005525

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags

DUNS number
829465157
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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30705031049172PRONOVAPN584GPN584G2026-01-07
30705031246175PRONOVAPN3558HPN3558H2026-01-07
30705031097234PROLENEEH7583HEH7583H2025-11-11
30705031098439PROLENEEH7835HEH7835H2025-11-11
30705031116201PROLENEF1880F18802025-11-11
30705031098477PROLENEEH7897GEH7897G2025-04-22
30705031228348PROLENEEP8729HEP8729H2025-04-22
30705031228621PROLENEEP8767HEP8767H2025-04-22
30705031237807PROLENEW753GW753G2025-04-22
30705031050864ETHICONTPW10TPW102015-09-24
10705031050877ETHICONTPW20TPW202015-09-01
10705031050884ETHICONTPW30TPW302015-09-01
10705031050891ETHICONTPW32TPW322015-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
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
10630094199716Bioseal Inc.BIOSEALKGS2023-12-12
10630094199730Bioseal Inc.BIOSEALKGS2023-12-12
10630094199754Bioseal Inc.BIOSEALKGS2023-12-12
10630094199785Bioseal Inc.BIOSEALKGS2023-12-12
10630094199808Bioseal Inc.BIOSEALKGS2023-12-12
10630094997251Bioseal Inc.BIOSEALKGS2023-12-12
10630094997329Bioseal Inc.BIOSEALKGS2023-12-12
10630094997428Bioseal Inc.BIOSEALKGS2023-12-12
10630094997626Bioseal Inc.BIOSEALKGS2023-12-12
10630094199310Bioseal Inc.BIOSEALKGS2023-12-11
10630094194490Bioseal Inc.BIOSEALKGS2023-10-11
10630094194681Bioseal Inc.BIOSEALKGS2023-10-11
10630094192342Bioseal Inc.BIOSEALKGS2023-10-09
10630094192397Bioseal Inc.BIOSEALKGS2023-10-09
10630094192410Bioseal Inc.BIOSEALKGS2023-10-09
20888277383149MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KGS2023-10-09
00850291007420FlowStasis Single-PackINARI MEDICAL INCKGS2023-07-19