FDA.reportPublic FDA data

UNICRYL M

Primary DI
16285379148848
Brand
UNICRYL M
Company
UNITED MEDICAL INDUSTRIES CO. LTD
Model
SD10036
Catalog number
SD10036
Device description
Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / 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
NEWSuture, Surgical, Absorbable, Polydioxanone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042285000UNICRYL MUnited Medical Industries Co. , Ltd.2004-12-10NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16285379148848PrimaryGS10
06285379148841Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1628537914884816285379148848
06285379148841062853791488416285379148841

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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
16285379148824UNICRYL quickDW12922DW129222020-04-30
16285379148831UNIGLACTINDW11555DW115552020-04-30
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

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08809963477384MINTHans Biomed Corp.NEW2026-07-28
08809963477445MINTHans Biomed Corp.NEW2026-07-28
08809963477858MINTHans Biomed Corp.NEW2026-07-28
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