Adroit Surgical

Primary DI
00859290006229
Brand
Adroit Surgical
Company
TRUER MEDICAL, INC.
Model
90546
Catalog number
VB-3001
Device description
The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctracheal tube 6.0 mm ID and larger for adult patients to guide the direction of the endotracheal tube (ETT) between the vocal cords. The Tactical Voir Bougije has clearly marked colored bands (patent pending) that allow the user to quickly insert the Bougie the correct distance into the trachea. The product has been designed for use by EMS and healthcare practitioners trained and experienced in airway management techniques.
Published
2018-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCDBougie, Esophageal, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCDBougie, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859290006226PackageGS110In Commercial Distribution
20859290006223PackageGS110In Commercial Distribution
00859290006229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000622610859290006226
2085929000622320859290006223
00859290006229008592900062298592900062290859290006229

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal bougie, single-useA cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7146289785ctruitt@truermedical.com
7146289785ttruitt@truermedical.com
4255772713phagen@adroitsurgical.com

Regulatory Flags#

DUNS number
003530786
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859290006489Sharn by MarketlabSharn SSP-4002024-10-29
10859290006486Sharn by MarketlabSharn SSP-4002024-10-29
00859290006472HP to 3.5mm Phonojack Cable with Shrinkwrap70309703092024-01-16
00859290006465Truer Bougie Coiled905532023-09-22
10859290006462Truer Bougie Coiled905532023-09-22
00859290006441400 Series Right Angle Cable (80 cm)703232023-07-19
00859290006458400 Series Right Angle Cable (160 cm)703262023-07-19
00859290006359Pediatric Stylet90201902012022-06-30
00859290006342Adult Stylet90200902002022-06-30
00859290006434CO EX LINE 96'X.048'X112' M/M90116901162022-12-09
00859290006410Nasal Cannula 90413904132022-09-08
10859290006417Nasal Cannula 90413904132022-09-08
00859290006236Truer Bougie905522022-08-29
00859290006274Gas Sampling Line 120'x.048'x.108' M/F90101901012022-06-30
00859290006281Gas Sampling Line 120'x.040'x.112' M/M 90148901482022-06-30
00859290006298Gas Sampling Line 120'X.050'x.108' M/M90150901502022-06-30
00859290006304GAS SAMPLING LINE 120'x.050'x.108' M/F90151901512022-06-30
00859290006311GAS SAMPLING LINE 96'x.050'x.112' MM90156901562022-06-30
00859290006328GAS SAMPLING LINE 120' X .050' X .112' M/M90158901582022-06-30
00859290006267Gas Sampling Line 120 x .048 x .108 M/M CO-EX90100901002022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183519285BR Surgical, LLCBR Surgical, LLCKCD2024-06-10
00859290006465Truer Bougie CoiledTRUER MEDICAL, INC.KCD2023-09-22
10859290006462Truer Bougie CoiledTRUER MEDICAL, INC.KCD2023-09-22
00859290006236Truer BougieTRUER MEDICAL, INC.KCD2022-08-29
00859290006212Adroit surgicalTRUER MEDICAL, INC.KCD2018-01-23
20859290006223Adroit SurgicalTRUER MEDICAL, INC.KCD2018-01-23