FDA UDI In Commercial Distribution 🇺🇸 United States

Richard-Allan® Vessel Loop

DI: 00887761007239 · Model: 3901 · ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2

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Basic Information

Brand Name
Richard-Allan® Vessel Loop
Primary DI
00887761007239
Version / Model
3901
Company Name
ASPEN SURGICAL PRODUCTS, INC.
Labeler DUNS
027680821
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2019-06-19
Public Version
4
Public Version Date
2021-03-04
Public Version Status
Update
Public Device Record Key
1737ae99-66bb-492c-bbc7-f0eac1586cb1

Device Description

Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KDC INSTRUMENT, SURGICAL, DISPOSABLE

GMDN Terms

Code Name
61916 Surgical vessel loop

Identifiers

Type ID
Package 10887761007236
Primary 00887761007239
Unit of Use 80887761007235

Customer Contacts