FDA.reportPublic FDA data

WECK

Primary DI
24026704112511
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN027866
Catalog number
332802-000010
Device description
Extraction bag, for 10 mm trocars
Published
2018-09-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGYBAG, INTESTINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGYBag, IntestineGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704112511PackageGS15In Commercial Distribution
44026704112515PackageGS144In Commercial Distribution
14026704112514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670411251124026704112511
4402670411251544026704112515
1402670411251414026704112514

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
507073870711913M™ Steri-Drape™3M COMPANYKGY2026-04-17
10885632426605HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20885632426602HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20748426262599Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00748426262595Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00888937027891LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027907LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027914LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027884LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027895LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027901LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027918LapSacCoopersurgical, Inc.KGY2025-09-03
00748426144037Medline-MicrotekMicrotek Medical LLCKGY2025-07-28
10748426144034Medline-MicrotekMicrotek Medical LLCKGY2025-07-28
10192253067873CONVERTORSCardinal Health 200, LLCKGY2025-06-30
50192253067871CONVERTORSCardinal Health 200, LLCKGY2025-06-30
16931918131153AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
06931918131156AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
00748426123568Cardinal HealthMicrotek Medical LLCKGY2024-09-26
30748426123569Cardinal HealthMicrotek Medical Inc.KGY2024-09-26
16931918199078AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
26931918199075AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
G026085001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026086001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026087001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026088001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
00749756253956DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
50749756253951DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
00827002156562LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157361LapSacCOOK INCORPORATEDKGY2020-10-02