FDA.reportPublic FDA data

UNICRYL quick

Primary DI
16285379148824
Brand
UNICRYL quick
Company
UNITED MEDICAL INDUSTRIES CO. LTD
Model
DW12922
Catalog number
DW12922
Device description
Braided Coated Polyglycolic Acid (PGA) (Fast Absorbing) Synthetic 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
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
K072644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072644000UNICRYL QUICKUnited Medical Industries Co. , Ltd.2007-11-07GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16285379148824PrimaryGS10
06285379148827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1628537914882416285379148824
06285379148827062853791488276285379148827

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA 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 device(s) [e.g., needle, passer] intended to facilitate suture application. 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 Diameter0.2Millimeter

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
16285379148831UNIGLACTINDW11555DW115552020-04-30
16285379148848UNICRYL MSD10036SD100362020-04-30
16285379148855UNICAPRONEDW13902RUDW13902RU2020-04-30
16285379148879UNISILKDW2943DW29432020-04-30
16285379148886UNISILK VSD2007SD20072020-04-30
16285379148893UNIMIDEDW3261RDW3261R2020-04-30
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
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