UNIGLACTIN DW11555

GUDID 06285379148834

Braided Coated Polyglactin Synthetic Absorbable Surgical Sututres / Ligatures

UNITED MEDICAL INDUSTRIES CO. LTD

Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Primary Device ID06285379148834
NIH Device Record Key743f684e-b4e2-44e4-b53d-9f41d5038d97
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIGLACTIN
Version Model NumberDW11555
Catalog NumberDW11555
Company DUNS535040901
Company NameUNITED MEDICAL INDUSTRIES CO. LTD
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa
Phone+966112650665
Emailqa@unimed.com.sa

Device Dimensions

Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter
Outer Diameter0.4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106285379148834 [Unit of Use]
GS116285379148831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

Devices Manufactured by UNITED MEDICAL INDUSTRIES CO. LTD

06285379148810 - UNICRYL2020-05-08 Braided Coated Polyglycolic Acid (PGA) Synthetic Absorbable Surgical Sutures / Ligatures.
06285379148827 - UNICRYL quick2020-05-08 Braided Coated Polyglycolic Acid (PGA) (Fast Absorbing) Synthetic Absorbable Surgical Sututres / Ligatures
06285379148834 - UNIGLACTIN2020-05-08Braided Coated Polyglactin Synthetic Absorbable Surgical Sututres / Ligatures
06285379148834 - UNIGLACTIN2020-05-08 Braided Coated Polyglactin Synthetic Absorbable Surgical Sututres / Ligatures
06285379148841 - UNICRYL M2020-05-08 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures.
06285379148858 - UNICAPRONE2020-05-08 Monofilament Polyglecaprone 25 Synthetic Absorbable Surgical Sututres / Ligatures
06285379148865 - UNIPRO2020-05-08 Monofilament Polypropylene Synthetic non-absorbable Surgical Sututres / Ligatures
06285379148872 - UNISILK2020-05-08 Braided Silk, Natural Non-Absorbable Surgical Sututres / Ligatures
06285379148889 - UNISILK V2020-05-08 Virgin Silk, Natural Non-Absorbable Surgical Sututres / Ligatures
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