FDA.reportPublic FDA data

Chromic Gut

Primary DI
20884521055893
Brand
Chromic Gut
Company
Covidien LP
Model
SG-635
Catalog number
SG-635
Device description
Absorbable Suture
Published
2015-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142656000
K885018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142656000Surgical Gut SutureCovidien2015-01-29GAL
K885018000ABSORBABLE SURGICAL GUT SUTURE*United States Surgical, A Division of Tyco Healthc1989-08-22GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521055893PackageGS136In Commercial Distribution
10884521055896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105589320884521055893
1088452105589610884521055896

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
Length30Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10652927111276DemeGUTDemetech CorporationGAL2019-07-22
10652927121824DemeGUTDemetech CorporationGAL2019-07-22
10652927129097DemeGUTDemetech CorporationGAL2019-07-22
10652927148821DemeGUTDemetech CorporationGAL2019-07-22
10652927150497DemeGUTDemetech CorporationGAL2019-07-22
10652927150503DemeGUTDemetech CorporationGAL2019-07-22
10652927152620DemeGUTDemetech CorporationGAL2019-07-22
10652927158448DemeGUTDemetech CorporationGAL2019-07-22
10652927158516DemeGUTDemetech CorporationGAL2019-07-22
10652927158547DemeGUTDemetech CorporationGAL2019-07-22
10652927158820DemeGUTDemetech CorporationGAL2019-07-22
10652927159322DemeGUTDemetech CorporationGAL2019-07-22
10652927159339DemeGUTDemetech CorporationGAL2019-07-22
10652927159346DemeGUTDemetech CorporationGAL2019-07-22
10652927159353DemeGUTDemetech CorporationGAL2019-07-22
10652927159360DemeGUTDemetech CorporationGAL2019-07-22
10652927160984DemeGUTDemetech CorporationGAL2019-07-22
10652927160991DemeGUTDemetech CorporationGAL2019-07-22
10652927161004DemeGUTDemetech CorporationGAL2019-07-22
10652927162117DemeGUTDemetech CorporationGAL2019-07-22
10652927163978DemeGUTDemetech CorporationGAL2019-07-22
10652927165361DemeGUTDemetech CorporationGAL2019-07-22
10652927170112DemeGUTDemetech CorporationGAL2019-07-22
10652927177678DemeGUTDemetech CorporationGAL2019-07-22
10652927185246DemeGUTDemetech CorporationGAL2019-07-22
10652927188438DemeGUTDemetech CorporationGAL2019-07-22
10652927194088DemeGUTDemetech CorporationGAL2019-07-22
10652927197508DemeGUTDemetech CorporationGAL2019-07-22
10652927198604DemeGUTDemetech CorporationGAL2019-07-22
10652927199489DemeGUTDemetech CorporationGAL2019-07-22