FDA.reportPublic FDA data

Quill

Primary DI
00848782040179
Brand
Quill
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
VLO-4222
Catalog number
VLO-4222
Device description
Polypropylene,Blue,1,45cm,Taper Point,CT-2,Uni-Directional
Published
2021-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAWSuture, nonabsorbable, synthetic, polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151112000Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech2015-09-10GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782040176PackageGS112In Commercial Distribution
00848782040179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878204017610848782040176
00848782040179008487820401798487820401790848782040179

GMDN Terms#

Term, Definition table
TermDefinition
Barbed polyolefin/fluoropolymer sutureA single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) or fluoropolymer (e.g., polyvinylidene fluoride) intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) to eliminate the need to tie a knot, and may include disposable suture application devices. It provides temporary wound support until the wound heals to withstand normal stress, after which it may be removed. It does not include antimicrobial materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782006021OnatecOB112210OB1122102022-04-26
00848782006038OnatecOB211830OB2118302022-04-26
00848782006045OnatecOB211845OB2118452022-04-26
00848782006052OnatecOB311345OB3113452022-04-26
00848782006069OnatecOB341902OB3419022022-04-26
00848782006076OnatecOB341920OB3419202022-04-26
00848782006083OnatecOB341925OB3419252022-04-26
00848782006090OnatecOB351102OB3511022022-04-26
00848782006106OnatecOB351345OB3513452022-04-26
00848782006113OnatecOB418535OB4185352022-04-26
00848782006120OnatecOB418545OB4185452022-04-26
00848782006137OnatecOB468055OB4680552022-04-26
00848782006144OnatecOB468530OB4685302022-04-26
00848782006151OnatecOB468535OB4685352022-04-26
00848782006168OnatecOB468545OB4685452022-04-26
00848782006175OnatecOB468555OB4685552022-04-26
00848782006182OnatecOB498545OB4985452022-04-26
00848782008421"C22 5-0 Grn Brd Pvn 18""/45cm"1176B11762015-10-20
00848782008438"C6 4-0 Grn Brd Pvn 18""/45cm"1180B11802015-10-20
00848782008445"C6 4-0 Wht Brd Pvn 18""/45cm"1205B12052015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07