FDA.reportPublic FDA data

Stent Buttons

Primary DI
34063107100452
Brand
Stent Buttons
Company
Boston Medical Products, Inc.
Model
323011
Catalog number
323011
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
34063107100452PackageGS11In Commercial Distribution
14063107100458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3406310710045234063107100452
1406310710045814063107100458

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags#

DUNS number
131855157
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063107102865Montgomery® Safe-T-Tube™ Plug/Ring Set3610863610862024-09-28
14063107102872Montgomery® Safe-T-Tube™ 15 mm Adaptor3610873610872024-09-28
14063107102889Montgomery® Safe-T-Tube™ Plug/Ring Set3611063611062024-09-28
14063107102896Montgomery® Safe-T-Tube™ 15 mm Adaptor3611073611072024-09-28
14063107102902Montgomery® Safe-T-Tube™ Plug/Ring Set3611163611162024-09-28
14063107102919Montgomery® Safe-T-Tube™ 15 mm Adaptor3611173611172024-09-28
14063107102926Montgomery® Safe-T-Tube™ Plug/Ring Set3611263611262024-09-28
14063107102933Montgomery® Safe-T-Tube™ 15 mm Adaptor3611273611272024-09-28
14063107102940Montgomery® Safe-T-Tube™ Plug/Ring Set3611463611462024-09-28
14063107102957Montgomery® Safe-T-Tube™ 15 mm Adaptor3611473611472024-09-28
14063107103060Montgomery® Safe-T-Tube™4600084600082024-09-28
14063107103077Montgomery® Safe-T-Tube™460008R460008R2024-09-28
14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28

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