FDA.report

Lap Scope WarmOR

Primary DI
09349967003282
Brand
Lap Scope WarmOR
Company
THE O R COMPANY PTY LTD
Model
SW-5-10-R
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

Related Records

Product Codes

CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09349967003275PackageGS125In Commercial Distribution
09349967003282PackageGS18In Commercial Distribution
09349967003268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09349967003275093499670032759349967003275
09349967003282093499670032829349967003282
09349967003268093499670032689349967003268

GMDN Terms

TermDefinition
Instrument warmer, electricAn electrically-powered heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of a tabletop device that has recesses or wells for placement of the instrument insertion portion, a heating element, a thermostat and operating controls.

Sterilization Methods

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

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19349967004972Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
19349967004989Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
19349967005016Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
19349967005061Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
19349967005078Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
19349967005085Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
19349967005092Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
19349967005108Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
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29349967005006ColpotomizOR Tube SystemCTS45-TV2023-04-04
09349967000724LapPakORW-18W-182018-06-23
09349967001448ColpotomizOR Tube35mmC35-TV2017-11-16
09349967001479ColpotomizOR Tube45mmC45-TV2017-11-16
09349967002261Uterine ElevatOR ProUE-TVPRO-322017-07-19
09349967002292Uterine ElevatOR ProUE-TVPRO-352017-07-19
09349967002322Uterine ElevatOR ProUE-TVPRO-372017-07-19
09349967002353Uterine ElevatOR ProUE-TVPRO-402017-07-19
09349967002773Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002803Uterine ElevatOR ProUE-TVPRO-352018-01-31

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