FDA.report

Sterion® Vessel Loop

Primary DI
00840113229338
Brand
Sterion® Vessel Loop
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
011013BBI
Device description
Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00840113229338PackageGS11000In Commercial Distribution
00840113229321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113229338008401132293388401132293380840113229338
00840113229321008401132293218401132293210840113229321

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

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