FDA.reportPublic FDA data

NA

Primary DI
50849771050778
Brand
NA
Company
KEY SURGICAL, INC.
Model
Vascular Loops
Catalog number
VL202
Device description
Vascular Loops, Sterile, Blue, Mini, 18-inch long, 2 per package
Published
2024-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896676000KEY VASCULAR LOOPSKey Surgical, Inc.1990-02-27KDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50849771050778PackageGS110In Commercial Distribution
00849771030843PreviousGS10
10849771050770PrimaryGS10
00849771050773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5084977105077850849771050778
00849771030843008497710308438497710308430849771030843
1084977105077010849771050770
00849771050773008497710507738497710507730849771050773

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vessel loopA nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
2
DM exempt
false
Premarket exempt
false
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160500040Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2025-10-28
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160382119MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-04
10653160381501MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-18
10653160381228MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160381334MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160379874CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-09-11
10653160379232MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-08-28
10653160375128MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160375340MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160374183CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-05-02
10653160369592CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-18
10653160369462CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-11
10653160369431CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160369448CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160365815CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-09-05
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10705031470507MERSILENEETHICON, LLCKDC2023-05-30
10653160360766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-05-29
10653160359197CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-03-17
10810102270921Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270938Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270945Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270952Dermapac, Inc.Dermapac Inc.KDC2022-09-12