FDA.reportPublic FDA data

Sohn's Dilators

Primary DI
00861838000323
Brand
Sohn's Dilators
Company
TOOLS FOR SURGERY, LLC
Model
SOD-03
Catalog number
SOD-03
Device description
Dilators used for the treatment of anal fissure.
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861838000323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861838000323008618380003238618380003230861838000323

GMDN Terms#

Term, Definition table
TermDefinition
Rectal dilator, reusableA surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter30Millimeter
Outer Diameter35Millimeter
Outer Diameter40Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

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00860013482138ZZIREN® Orogastric TubeZZ-SGT-36ZZ-SGT-362025-11-21
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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
00861838000354Colorectal Air Syringe-OPALT-30ALT-302019-09-26
00861838000361Colorectal Air Syringe-LPALT-50ALT-502019-09-26
00861838000378Bariatric Air SyringeALT-BAALT-BA2019-09-26
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