FDA.report

Richard-Allan® Vessel Loop

Primary DI
10887761007236
Brand
Richard-Allan® Vessel Loop
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
3901
Device description
Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures
Published
2019-06-19
Public version status
Update
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
10887761007236PackageGS150In Commercial Distribution
00887761007239PrimaryGS10
80887761007235Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088776100723610887761007236
00887761007239008877610072398877610072390887761007239
8088776100723580887761007235

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
2
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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