FDA.reportPublic FDA data

CrossCounty

Primary DI
10884521539723
Brand
CrossCounty
Company
Covidien LP
Model
SDATSW01
Catalog number
SDATSW01
Device description
Transbronchial Access Tool;Straight Wire
Published
2016-09-24
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

Contact Domains#

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
10884521539723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452153972310884521539723

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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
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
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810116024049Dornier MedTech DORNIER MEDTECH AMERICA, INC.EOQ2026-03-24
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
06975202770294EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770300EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770317EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770478EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770485EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770492EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770508EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770515EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770522EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
00886874124871Ion Tomosynthesis BoardINTUITIVE SURGICAL, INC.EOQ2025-11-11
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