FDA.reportPublic FDA data

NA

Primary DI
10886705003983
Brand
NA
Company
Medos International Sàrl
Model
214615
Catalog number
214615
Device description
Knot Manipulator - Full Loop
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705003983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500398310886705003983

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic suturing unitA manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435561MillenniumAvalign Technologies, Inc.HCF2026-10-20
G453521954312M0PEAK MEDICALPeak Medical Distribution Inc.HCF2026-10-20
14026704937452WECKTELEFLEX INCORPORATEDHCF2026-08-18
14026704937469WECKTELEFLEX INCORPORATEDHCF2026-08-18
14026704937476WECKTELEFLEX INCORPORATEDHCF2026-08-18
00198506091865ELMED INCORPORATEDELMED INCORPORATEDHCF2026-07-10
05060411983021Crilewood Needle Holder 150mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411984486De Bakey Needle Holder 180mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411985032Castroviejo Needle Holder with Lock 145mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411986961Barraquer Needle Holder 120mm, Curved 12mm Jaws, non lockingDTR MEDICAL LIMITEDHCF2026-06-10
00198506091285ELMED INCORPORATEDELMED INCORPORATEDHCF2026-06-09
00192896123441Barraquer Anis Needle HolderSONTEC INSTRUMENTS, INC.HCF2026-06-02
00198506090653ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-12
00198506090486ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-05
14026704937131WECKTELEFLEX INCORPORATEDHCF2026-04-24
00840343727451Gen2SURGIX MEDICAL LLCHCF2026-04-22
04058749044812NAFehling Instruments GmbH & Co. KGHCF2026-04-22
00198506090035ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-08
00198506089893ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-02
04058749121087NAFehling Instruments GmbH & Co. KGHCF2026-03-05
00198506088223ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-27
00198506088162ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506088179ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506087660ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00198506087776ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00848657077989AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00848657077996AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00850012846512C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
10850012846519C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
04058749118711NAFehling Instruments GmbH & Co. KGHCF2025-12-08