FDA.reportPublic FDA data

Premium UNIFY Fast Plain Gut Sutures

Primary DI
00814639026481
Brand
Premium UNIFY Fast Plain Gut Sutures
Company
APPLIED DENTAL, INC.
Model
PSRJ-518A13
Catalog number
PSRJ-518A13
Device description
"Premium UNIFY Fast Absorbing Gut Sutures, Small 5-0, 13mm 3/8 Circle Conventional Cut, 18"""
Published
2024-05-21
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
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000542000PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPArc Medical Supplies (Beijing) Co, Ltd.2000-04-28GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639026488PackageGS112In Commercial Distribution
20814639026485PackageGS1100In Commercial Distribution
00814639026481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902648810814639026488
2081463902648520814639026485
00814639026481008146390264818146390264810814639026481

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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, and is subsequently absorbed by enzymatic degradation. 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
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
00814639021615UNIFY PGA Surgical SuturesXS-G618R11-U2015-08-21
00814639021622UNIFY PGA Surgical SuturesXS-G718R112015-08-21
00814639021660UNIFY Nylon Surgical SuturesXXS-N1012S6D2015-08-21
00814639021677UNIFY Nylon Surgical SuturesXXS-N807T62015-08-21
00814639021950Premium UNIFY PP SuturesPSP-518R132015-08-21
00814639021967Premium UNIFY Polypropylene SuturesPSP-618R132015-08-21
00814639022414Premium UNIFY PP SuturesPMP-518R192016-11-09
00814639022421Premium UNIFY PP SuturesPMP-418R192016-11-09
00814639022438Premium UNIFY PP SuturesPSP-418R132016-11-09
00814639022803Premium UNIFY PP SuturesPMP-418R162016-11-09
00814639023602UNIFY Nylon Surgical SuturesXXS-N1007S62017-08-02
00814639023732Premium UNIFY PP SuturesPLP-427R242020-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052790SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052806SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052813SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052820SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052837SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052844SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052851SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052875SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052882SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052899SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052905SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052912SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052929SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052936SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06