FDA.reportPublic FDA data

ETHICON

Primary DI
30705031005949
Brand
ETHICON
Company
ETHICON, LLC
Model
4994H
Catalog number
4994H
Device description
Chromic Gut, 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
30705031005949PackageGS136In Commercial Distribution
10705031005945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503100594930705031005949
1070503100594510705031005945

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA sterile, 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 needle intended to be disposed of after single use. 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
10705031064669MERSILENEF1506F15062026-08-25
10705031064683MERSILENEF1532F15322026-08-25
10705031064706MERSILENEF1534F15342026-08-25
10705031064805MERSILENEF2502F25022026-08-25
10705031064812MERSILENEF2503F25032026-08-25
10705031064904MERSILENEF2515F25152026-08-25
10705031064959MERSILENEF2520F25202026-08-25
10705031064973MERSILENEF2525F25252026-08-25
10705031065185MERSILENEF2570F25702026-08-25
10705031065369MERSILENEFR832FR8322026-08-25
10705031089020ETHILON2871G2871G2026-08-25
10705031096479ETHILONEH7436GEH7436G2026-08-25
10705031097421MERSILENEEH7638HEH7638H2026-08-25
10705031097599MERSILENEEH7684HEH7684H2026-08-25
10705031097865MERSILENEEH7750HEH7750H2026-08-25
10705031241060MERSILENEF1533HF1533H2026-08-25
10705031241077MERSILENEF2506HF2506H2026-08-25
10705031241107MERSILENEF2514HF2514H2026-08-25
10705031241114MERSILENEF2516HF2516H2026-08-25
10705031241138MERSILENEF2520HF2520H2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052455SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-08-26
00840118621410Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621427Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621434Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621441Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00814639026962Premium UNIFY Fast Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026979Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026993Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027020Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027051Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06