FDA.reportPublic FDA data

Circular Stapler Head Sizer Set

Primary DI
00860002701394
Brand
Circular Stapler Head Sizer Set
Company
TOOLS FOR SURGERY, LLC
Model
HSS-10
Catalog number
HSS-10
Device description
Circular Stapler Head Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable head sizers that are used to assist in choosing surgical stapler size.
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002701394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002701394008600027013948600027013940860002701394

GMDN Terms#

Term, Definition table
TermDefinition
Colorectal sizerA hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. It is typically made of high-grade stainless steel and consists of a shaft handle at the proximal end and an oval-shaped head at the distal end that is introduced transanally. The device is typically available in a set of graduated sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter25Millimeter
Outer Diameter29Millimeter
Outer Diameter33Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
841842441
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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
00861838000354Colorectal Air Syringe-OPALT-30ALT-302019-09-26
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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