FDA.reportPublic FDA data

n.a.

Primary DI
04048551081983
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27224B
Catalog number
27224B
Device description
Bowl, for 27224
Published
2019-02-23
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
FFDEVACUATOR, BLADDER, MANUALLY OPERATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFDEvacuator, Bladder, Manually OperatedGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551081983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551081983040485510819834048551081983

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
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
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453040756Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFFD2025-08-25
05906168942228Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
05906168942211Dual Action Pump FootWISMED PL SP Z O OFFD2025-03-17
59061689422282Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
00810143891249Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
00810143891256Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
06936881168789Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168796Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168802Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168783Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168790Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168806Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
00190776299668MillenniumAvalign Technologies, Inc.FFD2023-06-23
05060460843666EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843697EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843727EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843758EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460845707EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460848043EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889374EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889404EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889435EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843680EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843710EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843741EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843765EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460845714EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460848050EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889398EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889428EnteralGBUK ENTERAL LIMITEDFFD2022-10-19