FDA.reportPublic FDA data

"GUT CH 4/0 18"" C6-PEARSON"

Primary DI
00848782005659
Brand
"GUT CH 4/0 18"" C6-PEARSON"
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
PL558B
Device description
"GUT CH 4/0 18"" C6-PEARSON"
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GALSUTURE, ABSORBABLE, NATURAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782005656PackageGS112In Commercial Distribution
00848782005659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878200565610848782005656
00848782005659008487820056598487820056590848782005659

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, 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 to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782006021OnatecOB112210OB1122102022-04-26
00848782006038OnatecOB211830OB2118302022-04-26
00848782006045OnatecOB211845OB2118452022-04-26
00848782006052OnatecOB311345OB3113452022-04-26
00848782006069OnatecOB341902OB3419022022-04-26
00848782006076OnatecOB341920OB3419202022-04-26
00848782006083OnatecOB341925OB3419252022-04-26
00848782006090OnatecOB351102OB3511022022-04-26
00848782006106OnatecOB351345OB3513452022-04-26
00848782006113OnatecOB418535OB4185352022-04-26
00848782006120OnatecOB418545OB4185452022-04-26
00848782006137OnatecOB468055OB4680552022-04-26
00848782006144OnatecOB468530OB4685302022-04-26
00848782006151OnatecOB468535OB4685352022-04-26
00848782006168OnatecOB468545OB4685452022-04-26
00848782006175OnatecOB468555OB4685552022-04-26
00848782006182OnatecOB498545OB4985452022-04-26
00848782008421"C22 5-0 Grn Brd Pvn 18""/45cm"1176B11762015-10-20
00848782008438"C6 4-0 Grn Brd Pvn 18""/45cm"1180B11802015-10-20
00848782008445"C6 4-0 Wht Brd Pvn 18""/45cm"1205B12052015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10652927158516DemeGUTDemetech CorporationGAL2019-07-22
10652927158547DemeGUTDemetech CorporationGAL2019-07-22
10652927158820DemeGUTDemetech CorporationGAL2019-07-22
10652927159322DemeGUTDemetech CorporationGAL2019-07-22
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10652927159346DemeGUTDemetech CorporationGAL2019-07-22
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10652927199489DemeGUTDemetech CorporationGAL2019-07-22