FDA.reportPublic FDA data

Colorectal Air Syringe-OP

Primary DI
00861838000354
Brand
Colorectal Air Syringe-OP
Company
TOOLS FOR SURGERY, LLC
Model
ALT-30
Catalog number
ALT-30
Device description
Expedite and standardize the 'bubble test' for colorectal anastomoses.
Published
2019-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCYBulb, Inflation, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCYBulb, Inflation, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861838000354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861838000354008618380003548618380003540861838000354

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope inflation bulbA device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6314444448info@toolsforsurgery.com

Regulatory Flags#

DUNS number
841842441
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013482107ZZIREN® Orogastric TubeZZ-GBT-32ZZ-GBT-322025-11-21
00860013482114ZZIREN® Orogastric TubeZZ-SGT-32ZZ-SGT-322025-11-21
00860013482121ZZIREN® Orogastric TubeZZ-GBT-36ZZ-GBT-362025-11-21
00860013482138ZZIREN® Orogastric TubeZZ-SGT-36ZZ-SGT-362025-11-21
00860013482145ZZIREN® Orogastric TubeZZ-GBT-40ZZ-GBT-402025-11-21
00860013482152ZZIREN® Orogastric TubeZZ-SGT-40ZZ-SGT-402025-11-21
00860002701387Circular Stapler Anvil Sizer SetANS-10ANS-102023-07-19
00860002701394Circular Stapler Head Sizer SetHSS-10HSS-102023-07-19
00860002701325Barbell Loop Ostomy DeviceBAR-2BAR-22023-07-17
00860002701349Barbell Loop Ostomy DeviceBAR-3BAR-32023-07-17
00860002701356Barbell Loop Ostomy DeviceBAR-4BAR-42023-07-17
00860002701363SIREN SGTSGT-36SGT-362023-07-17
00861838000330WIKI Drain, 15 Fr, 3 cm, 1 DrainWIK-15-3-1WIK-15-3-12023-07-17
00861838000347WIKI Drain, 15 Fr, 3 cm, 6 DrainsWIK-15-3-6WIK-15-3-62023-07-17
00860002701318Colorectal Air Syringe-OP EXALT-30EXALT-30EX2019-12-17
00860002701332Colorectal Air Syringe-LP EXALT-50EXALT-50EX2019-12-17
00861838000361Colorectal Air Syringe-LPALT-50ALT-502019-09-26
00861838000378Bariatric Air SyringeALT-BAALT-BA2019-09-26
00861838000316Hemorrhage Occluder Pin with ApplicatorHOP-APHOP-AP2019-09-26
00861838000309Hemorrhage Occluder PinHOP-03HOP-032019-09-19

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