FDA.reportPublic FDA data

TRUCLEARTM Obturator

Primary DI
03596010529442
Brand
TRUCLEARTM Obturator
Company
Smith & Nephew, Inc.
Model
7209384
Catalog number
7209384
Device description
TRUCLEAR OBTURATOR
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010529442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010529442035960105294423596010529442

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
109903521
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

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Primary DI, Brand, Company table
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16973672291162ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291179ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291186ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
06973672291196ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
00848657077439AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077514AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077521AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077545AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077569AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
26974880991445HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880991452HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
06974880991632HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880993401HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
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04048551418284NAKarl Storz GmbH & Co. KGHIH2025-03-27
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15420045516113Fluent Pro Waste BagHologic, Inc.HIH2024-10-15
15420045516137Fluent Pro Tissue TrapHologic, Inc.HIH2024-10-15
00850006759705Aveta Waste Management AccessoryMEDITRINA, INC.HIH2024-10-14
10850006759733Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIH2024-10-14
00850033976250HERizon Medical Endoscope Image Processor Minerva Surgical, Inc.HIH2024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeMinerva Surgical, Inc.HIH2024-10-07
04048551390405n.a.Karl Storz GmbH & Co. KGHIH2019-02-23
04048551083451n.a.Karl Storz GmbH & Co. KGHIH2018-08-21