FDA.reportPublic FDA data

EEA

Primary DI
20884523006626
Brand
EEA
Company
Covidien LP
Model
020251
Device description
Reusable Sizer
Published
2018-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
20884523006626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300662620884523006626

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 Diameter34Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD500500Surgical DirectSurgical Direct, Inc.KOA2026-08-03
00198506093630ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-29
00198506092169ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-27
00198506091933ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093128ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093135ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506091759ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091810ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091841ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091858ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091889ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07