FDA.reportPublic FDA data

Oesophageal/ Laryngeal 4mm x 275mm, 30° angle, proximal bend with suction contro

Primary DI
05060212057877
Brand
Oesophageal/ Laryngeal 4mm x 275mm, 30° angle, proximal bend with suction contro
Company
DTR MEDICAL LIMITED
Model
74-2083
Published
2024-10-14
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
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060212057877PackageGS125In Commercial Distribution
05060411982093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060212057877050602120578775060212057877
05060411982093050604119820935060411982093

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
424066509
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
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060212052162Sims Uterine SoundUSH20012024-10-14
05060411980471Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060411980662Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060411980730Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060411980747Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060411980792Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060411980853Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060411980860Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060411981218Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060411981225Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060411981232Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060411981249Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060411981256Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060411981263Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060411981270Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060411981386Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060411981560Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060411981577Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060411981799Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14
05060411981805Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24
00840314238559gSourceGSOURCE LLCJOL2025-11-24
00840314238566gSourceGSOURCE LLCJOL2025-11-24
00840314238573gSourceGSOURCE LLCJOL2025-11-24
00840314238580gSourceGSOURCE LLCJOL2025-11-24
00840314238597gSourceGSOURCE LLCJOL2025-11-24
00840314238603gSourceGSOURCE LLCJOL2025-11-24
00840314238610gSourceGSOURCE LLCJOL2025-11-24
00840314238627gSourceGSOURCE LLCJOL2025-11-24
00840314238634gSourceGSOURCE LLCJOL2025-11-24
00840314238641gSourceGSOURCE LLCJOL2025-11-24
00840314238658gSourceGSOURCE LLCJOL2025-11-24
00840314238665gSourceGSOURCE LLCJOL2025-11-24