FDA.reportPublic FDA data

n.a.

Primary DI
04048551045466
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
10313EM
Device description
Emergency Tracheoscope, sz. 5
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551045466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551045466040485510454664048551045466

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopy tubeA hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06937048207884UE DisplayZhejiang UE Medical CorpEOQ2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
14547410520580FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00860009430204Recon Steerable SheathSERPEX MEDICAL INC.EOQ2025-12-08
06975202770287EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
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06975202770300EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
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06975202770508EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770515EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770522EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
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00886874126301NoneINTUITIVE SURGICAL, INC.EOQ2025-10-23
10810068811275Extended Patient Introducer MountAuris Health, Inc.EOQ2025-09-04
06975339626624Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626631Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626642ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626655ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626666ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626673ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626680ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626697ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626709HDMI cableMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626716Power adapterMacroLux Medical Technology Co., Ltd.EOQ2025-08-23