FDA.reportPublic FDA data

UNIFY PGCL Surgical Sutures

Primary DI
00814639025545
Brand
UNIFY PGCL Surgical Sutures
Company
APPLIED DENTAL, INC.
Model
XS-Q518R11-C
Device description
"PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18"" Violet"
Published
2021-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130737000
K142810000
K173779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130737000SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.2014-01-14GAM
K142810000WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd.2014-11-14GAM
K173779000REXMONO, PDREXSm Eng Co., Ltd.2018-03-12GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639025542PackageGS112In Commercial Distribution
20814639025549PackageGS1100In Commercial Distribution
00814639025545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902554210814639025542
2081463902554920814639025549
00814639025545008146390255458146390255450814639025545

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@ad-surgical.com

Regulatory Flags#

DUNS number
017524666
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814639026856UNIFY Nylon Surgical SuturesXXS-N1012S7DXXS-N1012S7D2026-08-07
00814639026863UNIFY Nylon Surgical SuturesXXS-N1012S5DXXS-N1012S5D2026-08-07
00814639026962Premium UNIFY Fast Gut SuturesPXSRJ-618R11PXSRJ-618R112026-08-07
00814639026979Premium UNIFY Plain Gut SuturesPXSJ-618R11PXSJ-618R112026-08-07
00814639026993Premium UNIFY Plain Gut SuturesPXSJ-618R11DPXSJ-618R11D2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesPSJ-518R13DPSJ-518R13D2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesPSJ-418K13PSJ-418K132026-08-07
00814639027020Premium UNIFY Chromic SuturesPSC-518R13DPSC-518R13D2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesPXSC-618R11PXSC-618R112026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesPXSC-618R11DPXSC-618R11D2026-08-07
00814639027051Premium UNIFY Chromic SuturesPSC-418R13DPSC-418R13D2026-08-07
00814639025606UNIFY PGA Surgical SuturesS-G518XR13-U2026-07-17
00814639025781UNIFY PGA Surgical SuturesS-G518XR13-U2023-04-12
00814639023374SUPERFITA520-LTX602020-08-06
00814639023381SUPERFITA520-LTX652020-08-06
00814639023398SUPERFITA520-LTX702020-08-06
00814639023404SUPERFITA520-LTX752020-08-06
00814639023411SUPERFITA520-LTX802020-08-06
00814639026832UNIFY MicroSutures SilkXXS-S618S6DXXS-S618S6D2026-04-27
00814639026849UNIFY MicroSutures SilkXS-S618R11DXS-S618R11D2026-04-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
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08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
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