FDA.reportPublic FDA data

LapPakOR

Primary DI
09349967000724
Brand
LapPakOR
Company
THE O R COMPANY PTY LTD
Model
W-18
Catalog number
W-18
Device description
Single piece bowel retractor
Published
2018-06-23
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

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967000717PackageGS15In Commercial Distribution
09349967000724PackageGS16In Commercial Distribution
09349967000700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967000717093499670007179349967000717
09349967000724093499670007249349967000724
09349967000700093499670007009349967000700

GMDN Terms#

Term, Definition table
TermDefinition
Viscera retention paddleA sterile, hand-held, flat device designed to be temporarily placed within a body cavity to retain and protect organs (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is in the form of a thin, flexible, synthetic polymer paddle that may have an attached cord that remains outside the body to assist in device removal prior to external wound closure. This is a single-use device.

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
00843511123086Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123093Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00613244000011Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000028Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000035Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000042Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000066Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000004Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400001100Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400002800Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400003500Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400004200Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000059Breast Implant ProtectorADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400006600Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
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90841823104277Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104284Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104291Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104307Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104314Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104321Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104338Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104345Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
00816101010363Cross Element Guide RetainerTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010370Cross Element Guide SleeveTOBY ORTHOPAEDICSGCZ2020-08-28