FDA.report

NA

Primary DI
50849771050808
Brand
NA
Company
KEY SURGICAL, INC.
Model
Vascular Loops
Catalog number
VL205
Device description
Vascular Loops, Sterile, Red, Maxi, 18-inch long, 2 per package
Published
2023-09-25
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

Related Records

Contact Domains

Product Codes

CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50849771050808PackageGS110In Commercial Distribution
00849771030874PreviousGS10
10849771050800PrimaryGS10
00849771050803Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5084977105080850849771050808
00849771030874008497710308748497710308740849771030874
1084977105080010849771050800
00849771050803008497710508038497710508030849771050803

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length18Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags

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

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00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
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10724995225022Electro LubeEL201EL2012024-10-03
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