FDA.reportPublic FDA data

UNIMIDE

Primary DI
16285379148893
Brand
UNIMIDE
Company
UNITED MEDICAL INDUSTRIES CO. LTD
Model
DW3261R
Catalog number
DW3261R
Device description
Monofilament, Polyamide, Synthetic, Non-absorbable Surgical Sututres / Ligatures
Published
2020-04-30
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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042284000UNIMIDEUnited Medical Industries Co. , Ltd.2004-12-03GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16285379148893PrimaryGS10
06285379148896Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1628537914889316285379148893
06285379148896062853791488966285379148896

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+966112650665qa@unimed.com.sa

Regulatory Flags#

DUNS number
535040901
Device count
12
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16285379148909UNIMDE BDW5723DW57232020-04-30
16285379148923UNIESTERDT6303DDT6303D2020-04-30
16285379148930UNIESTER CDW7382DW73822020-04-30
16285379148862UNIPRODW9443DW94432020-04-30
16285379148817UNICRYLDW8515DW85152020-04-30
16285379148824UNICRYL quickDW12922DW129222020-04-30
16285379148831UNIGLACTINDW11555DW115552020-04-30
16285379148848UNICRYL MSD10036SD100362020-04-30
16285379148855UNICAPRONEDW13902RUDW13902RU2020-04-30
16285379148879UNISILKDW2943DW29432020-04-30
16285379148886UNISILK VSD2007SD20072020-04-30
16285379148916UNIMIDE CDW3742DW37422020-04-30
06285379148810UNICRYLDW8515DW85152020-04-30
06285379148827UNICRYL quickDW12922DW129222020-04-30
06285379148834UNIGLACTINDW11555DW115552020-04-30
06285379148841UNICRYL MSD10036SD100362020-04-30
06285379148858UNICAPRONEDW13902RUDW13902RU2020-04-30
06285379148865UNIPRODW9443DW94432020-04-30
06285379148872UNISILKDW2943DW29432020-04-30
06285379148889UNISILK VSD2007SD20072020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814639026856UNIFY Nylon Surgical SuturesAPPLIED DENTAL, INC.GAR2026-08-07
00814639026863UNIFY Nylon Surgical SuturesAPPLIED DENTAL, INC.GAR2026-08-07
00860011435938TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435945TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435952TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435969TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06