FDA.reportPublic FDA data

2d13 -2- Cl Ppn 14x14

Primary DI
00848782016877
Brand
2d13 -2- Cl Ppn 14x14
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
JA-1001Q
Catalog number
JA-1001Q
Device description
2d13 -2- Cl Ppn 14x14
Published
2015-10-21
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
K052373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052373000QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTUREQuill Medical, Inc.2005-09-26GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782016874PackageGS112In Commercial Distribution
00848782016877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878201687410848782016874
00848782016877008487820168778487820168770848782016877

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/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
00848782052455SharpointC926N2026-08-26
00848782052516SharpointA1702N2026-08-26
00848782052417SharpointB915N2026-07-06
00848782052424SharpointB926N2026-07-06
00848782052431SharpointB937N2026-07-06
00848782052448SharpointB948N2026-07-06
00848782052462SharpointC937N2026-07-06
00848782052486SharpointC959N2026-07-06
00848782052493SharpointM952N2026-07-06
00848782052509SharpointM963N2026-07-06
00848782052684SharpointB930N2026-07-06
00848782052691SharpointB931N2026-07-06
00848782052707SharpointC960N2026-07-06
00848782052714SharpointB932N2026-07-06
00848782052721SharpointB933N2026-07-06
00848782052738SharpointC961N2026-07-06
00848782052745SharpointC962N2026-07-06
00848782052752SharpointC963N2026-07-06
00848782052776SharpointC965N2026-07-06
00848782052783SharpointB934N2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224514TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
10705031097278PROLENEETHICON, LLCGAW2026-08-17
10705031097643PROLENEETHICON, LLCGAW2026-08-17
10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
10705031097919PROLENEETHICON, LLCGAW2026-08-17
10705031097995PROLENEETHICON, LLCGAW2026-08-17
10705031098008PROLENEETHICON, LLCGAW2026-08-17
10705031098039PROLENEETHICON, LLCGAW2026-08-17
10705031127838PROLENEETHICON, LLCGAW2026-08-17
10705031128491PROLENEETHICON, LLCGAW2026-08-17
10705031132641PROLENEETHICON, LLCGAW2026-08-17
10705031148284PROLENEETHICON, LLCGAW2026-08-17
10705031148314PROLENEETHICON, LLCGAW2026-08-17
10705031148697PROLENEETHICON, LLCGAW2026-08-17
10705031201965PROLENEETHICON, LLCGAW2026-08-17
10705031201989PROLENEETHICON, LLCGAW2026-08-17
10705031238251PROLENEETHICON, LLCGAW2026-08-17
10705031464995PROLENEETHICON, LLCGAW2026-08-17
10705031465015PROLENEETHICON, LLCGAW2026-08-17