FDA.reportPublic FDA data

ETHICON

Primary DI
30705031007189
Brand
ETHICON
Company
ETHICON, LLC
Model
636H
Catalog number
636H
Device description
Absorbable Surgical Suture
Published
2015-09-01
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
K946173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946173000STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.1995-01-09GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031007189PackageGS136In Commercial Distribution
10705031007185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503100718930705031007189
1070503100718510705031007185

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
079402290
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
10705031008724PERMA-HAND706G706G2015-09-01
10705031129931ETHICONW945W9452026-05-18
10705031239777ETHIBOND EXCELX4B37GX4B37G2018-01-25
10705031239784ETHIBOND EXCELX4B77GX4B77G2018-01-31
10705031462144ETHIBOND EXCEL10X52N10X52N2019-07-04
10705031462168ETHIBOND EXCEL10X72N10X72N2019-07-04
10705031462175ETHIBOND EXCEL10X66N10X66N2019-07-04
10705031468214ETHIBOND EXCELD7576ND7576N2021-05-08
10705031468221ETHIBOND EXCELD10048ND10048N2021-05-08
10705031468238ETHIBOND EXCELD7581ND7581N2021-05-08
10705031468245ETHIBOND EXCELD7924ND7924N2021-05-08
10705031468276ETHIBOND EXCELD8492ND8492N2021-05-08
10705031468320ETHIBOND EXCELD9079ND9079N2021-05-08
10705031468344ETHIBOND EXCELD9329ND9329N2021-05-08
10705031468351ETHIBOND EXCELD9607ND9607N2021-05-08
10705031468368ETHIBOND EXCELD9876ND9876N2021-05-08
10705031468375ETHIBOND EXCELD9885ND9885N2021-05-08
10705031468382ETHIBOND EXCELD9974ND9974N2021-05-08
10705031468399ETHIBOND EXCELDC423NDC423N2021-05-08
10705031468498ETHIBOND EXCELX32200HX32200H2021-05-08

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