FDA.reportPublic FDA data

UNIFY PGCL Surgical Sutures

Primary DI
10814639021735
Brand
UNIFY PGCL Surgical Sutures
Company
APPLIED DENTAL, INC.
Model
M-Q330R19
Device description
PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.
Published
2015-08-19
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639021735PackageGS112In Commercial Distribution
20814639021732PackageGS1100In Commercial Distribution
00814639021738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902173510814639021735
2081463902173220814639021732
00814639021738008146390217388146390217380814639021738

GMDN Terms#

Term, Definition table
TermDefinition
Poliglecaprone sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00814639023749Premium UNIFY PP SuturesPLP-327R242020-08-03
00814639024135UNIFY Nylon Surgical SuturesXXS-N905T52020-07-30
00814639024142UNIFY Nylon Surgical SuturesXXS-N1005T42020-07-30
00814639024791Premium UNIFY PP SuturesPMP-318R192020-08-03
00814639025538UNIFY PGCL Surgical SuturesXS-Q518R112021-04-23
00814639025545UNIFY PGCL Surgical SuturesXS-Q518R11-C2021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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