FDA.report

Premium UNIFY Polypropylene Sutures

Primary DI
10814639021964
Brand
Premium UNIFY Polypropylene Sutures
Company
APPLIED DENTAL, INC.
Model
PSP-618R13
Device description
Premium Polypropylene, Sm 6-0, 13mm 3/8 circle Rev Cut, 18"
Published
2015-08-21
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

Related Records

Contact Domains

Product Codes

CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications

CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10814639021964PackageGS112In Commercial Distribution
20814639021961PackageGS1100In Commercial Distribution
00814639021967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902196410814639021964
2081463902196120814639021961
00814639021967008146390219678146390219670814639021967

GMDN Terms

TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
10814639026747Premium UNIFY Silk SuturesPMS-318R192025-06-20
10814639026754Premium UNIFY Silk SuturesPMS-418R192025-06-20
10814639026761Premium UNIFY Silk SuturesPMS-518R192025-06-20
10814639026778Premium UNIFY Silk SuturesPSS-418R132025-06-20
10814639026785Premium UNIFY Silk SuturesPSS-518R132025-06-20
10814639026792Premium UNIFY Silk SuturesPSS-618R132025-06-20
10814639026563UNIFY Chromic Gut Surgical SuturesM-C318R192025-06-19
10814639026587UNIFY Chromic Gut Surgical SuturesM-C418R162025-06-19
10814639026594UNIFY Chromic Gut Surgical SuturesM-C518R162025-06-19
10814639026600UNIFY Chromic Gut Surgical SuturesS-C618R132025-06-19
10814639026617UNIFY Plain Gut SuturesS-J618R132025-06-19
10814639026624UNIFY Plain Gut Surgical SuturesL-J230R24L-J230R242025-06-19
10814639026648UNIFY Plain Gut SuturesM-J318R192025-06-19
10814639026655UNIFY Plain Gut SuturesM-J418R162025-06-19
10814639026662UNIFY Plain Gut SuturesM-J430R19M-J430R192025-06-19
10814639026679UNIFY Plain Gut SuturesM-J518R162025-06-19
10814639026686UNIFY Chromic Surgical Sutures M-C518R19 2025-06-19
10814639026693UNIFY Plain Gut SuturesM-J518R192025-06-19
10814639026730UNIFY Polyester Surgical SuturesL-E230R262025-06-19
10814639026808UNIFY Polyester Surgical SuturesS-E418R132025-06-19

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