C-QUR

Primary DI
00650862313406
Brand
C-QUR
Company
Atrium Medical Corporation
Model
31340
Device description
C-QUR FX, 10 in. X 14 in. (25.4 cm x 35.5 cm)
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082748000
K151386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082748000ATRIUM PROLITE S MESHAtrium Medical Corp.2009-01-14FTL
K151386000C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicAtrium Medical Corporation2015-10-22FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650862313406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862313406006508623134066508623134060650862313406

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA sterile, flat, or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications, and excludes devices designed specifically for diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051798999
Device count
1
Serial number
true
Expiration date on label
true

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Primary DI, Brand, Model table
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