FDA.reportPublic FDA data

"Retention Guard Suture Retention Plates - 3"""

Primary DI
10810805000214
Brand
"Retention Guard Suture Retention Plates - 3"""
Company
PRESERVATION SOLUTIONS INC
Model
RG-3
Device description
For the temporary, external anchoring of sutures and prevention of suture pull through.
Published
2018-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10810805000214PrimaryGS10
00810805000217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081080500021410810805000214
00810805000217008108050002178108050002170810805000217

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
2627236715brader@preservationsolutions.com

Regulatory Flags#

DUNS number
090266979
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810805000139ClearIt Anti-Fog ClothPS0012016-10-22
10810805000146ClearIt Anti-Fog Kit PS0032016-10-11
00810805000026Belzer UW Cold Storage Solution BUW-5002016-10-22
00810805000040Belzer UW Cold Storage Solution BUW-0012016-10-07
00810805000071Belzer UW Cold Storage SolutionBUW-0022016-10-22
00810805000095Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
00810805000101Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
00810805000156Waters IGL Cold Storage SolutionCSS/1000/US2016-10-22
00810805000163Waters IGL Cold Storage SolutionCSS/2000/US2016-10-22
00810805000170Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
00810805000224"StarGuard Suture Retention Plates - 7"""SG-72018-12-07
00810805000231"StarGuard Suture Retention Plates - 9"""SG-92018-12-07
10810805000092Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
10810805000108Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
10810805000177Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
00810805000187Wittmann PatchEWP20402016-10-22
00810805000194XTACXTAC2016-10-22
10810805000023Belzer UW Cold Storage Solution BUW-5002016-10-22
10810805000047Belzer UW Cold Storage Solution BUW-0012016-10-07
10810805000078Belzer UW Cold Storage SolutionBUW-0022016-10-22

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Primary DI, Brand, Company table
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