FDA.report

NA

Primary DI
50849771050792
Brand
NA
Company
KEY SURGICAL, INC.
Model
Vascular Loops
Catalog number
VL204
Device description
Vascular Loops, Sterile, White, Mini, 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
50849771050792PackageGS110In Commercial Distribution
00849771030867PreviousGS10
10849771050794PrimaryGS10
00849771050797Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5084977105079250849771050792
00849771030867008497710308678497710308670849771030867
1084977105079410849771050794
00849771050797008497710507978497710507970849771050797

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
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