FDA.reportPublic FDA data

Premium UNIFY PGLA Sutures

Primary DI
10814639023906
Brand
Premium UNIFY PGLA Sutures
Company
APPLIED DENTAL, INC.
Model
PXXLU-G027T40
Device description
Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Undyed, 27"
Published
2018-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K073614000
K161629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073614000WG-SURGICAL SUTURES WITH NEEDLEFoosin Medical Supplies, Inc.2008-04-30NEW
K161629000CRYLREXSm Eng Co., Ltd.2017-02-10GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639023906PackageGS112In Commercial Distribution
00814639023909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902390610814639023906
00814639023909008146390239098146390239090814639023909

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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 needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@AD-Surgical.com

Regulatory Flags#

DUNS number
017524666
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224453MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
10705031464285STRATAFIXETHICON, LLCGAM2023-03-24
10705031464292STRATAFIXETHICON, LLCGAM2023-03-24
10705031464308STRATAFIXETHICON, LLCGAM2023-03-24
10705031464315STRATAFIXETHICON, LLCGAM2023-03-24
10705031464322STRATAFIXETHICON, LLCGAM2023-03-24
10705031464339STRATAFIXETHICON, LLCGAM2023-03-24
10705031464346STRATAFIXETHICON, LLCGAM2023-03-24
10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24