FDA.report

n.a.

Primary DI
04048438005613
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
031447-10
Catalog number
031447-10
Device description
Tubing Set, Suction LAP, S-PILOT
Published
2019-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048438005613PrimaryGS10
04048438005606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048438005613040484380056134048438005613
04048438005606040484380056064048438005606

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags

DUNS number
315731430
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
10817183020810PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070109NARichard Wolf GmbHNKC2024-05-24
14897106955869andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
14897106955852andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
50628725007361CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007378CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007385CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007392CHSCanadian Hospital Specialties LimitedNKC2023-08-23
20326053102787Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102800Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102817Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
26931918199655AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2023-07-20
B382SD500011Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD50001M0Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD50001S0Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD500041Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD500001Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50000M0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50000S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD500021Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50002S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50003S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50004S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30