FDA.reportPublic FDA data

Suture PassOR Pro

Primary DI
09349967000625
Brand
Suture PassOR Pro
Company
THE O R COMPANY PTY LTD
Model
RSG-14/18F
Published
2019-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
09349967000588PackageGS110In Commercial Distribution
09349967000625PackageGS120In Commercial Distribution
09349967000571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967000588093499670005889349967000588
09349967000625093499670006259349967000625
09349967000571093499670005719349967000571

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter32Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744346235
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349967002759Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002780Uterine ElevatOR ProUE-TVPRO-352018-01-31
09349967002810Uterine ElevatOR ProUE-TVPRO-372018-01-31
09349967002841Uterine ElevatOR Pro UE-TVPRO-402018-01-31
09349967003268Lap Scope WarmORSW-5-10-R2019-03-27
09349967003442ColpotomizOR Tube SystemCTS35-TV2019-03-27
09349967003473ColpotomizOR Tube SystemCTS45-TV2019-03-27
09349967004036Skin MarkOR Fine TipSMOR-F2021-04-12
09349967004067Skin MarkOR Regular TipSMOR-R2021-04-12
09349967004210Laparoscopic Smoke EvacuatorLSE-012021-04-12
09349967004968Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
09349967004975Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
09349967004982Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
09349967005019Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
09349967005064Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
09349967005071Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
09349967005088Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
09349967005095Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
09349967005101Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776413446MillenniumAvalign Technologies, Inc.HCF2025-10-09
00198506085963ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-03
00198506072956ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082214ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082221ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
G453521053112M0PEAK MEDICALPeak Medical Distribution Inc.HCF2025-10-01
00190776411916MillenniumAvalign Technologies, Inc.HCF2025-09-25
00840217909952Wiggins medicalEbner Medical, LLCHCF2025-09-17
00198506085581ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-12
00198506085024ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-05
00198506084812ELMED INCORPORATEDELMED INCORPORATEDHCF2025-08-26
G4533352105310PEAK MEDICALPeak Medical Distribution Inc.HCF2025-08-13