FDA.reportPublic FDA data

PILLING

Primary DI
24026704536065
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008681
Catalog number
524042
Device description
INSTRUMENT GUIDE RUBBER CAP 5/PACK
Published
2016-09-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLOLASER, NEODYMIUM:YAG, PULMONARY SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLOLaser, Neodymium:Yag, Pulmonary SurgeryEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861921000LASER BRONCHOSCOPE SYSTEMPilling Co.1986-06-02LLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704536065PackageGS11In Commercial Distribution
04026704536061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670453606524026704536065
04026704536061040267045360614026704536061

GMDN Terms#

Term, Definition table
TermDefinition
Rigid bronchoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
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
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
24026704715514PILLINGTELEFLEX INCORPORATEDLLO2020-09-11
14026704715517PILLINGTELEFLEX INCORPORATEDLLO2020-09-11
24026704715347PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715354PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715361PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715378PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715385PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715392PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715408PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715415PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715422PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715439PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715446PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715453PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715460PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715477PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715484PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715491PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715507PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715521PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715538PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715545PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
24026704715552PILLINGTELEFLEX INCORPORATEDLLO2020-09-04
04055207022474VARIO-PORTRichard Wolf GmbHLLO2016-09-27
04055207022481VARIO-PORTRichard Wolf GmbHLLO2016-09-27
04055207022641VARIO-PORTRichard Wolf GmbHLLO2016-09-27
04055207022658VARIO-PORTRichard Wolf GmbHLLO2016-09-27
04055207008843NARichard Wolf GmbHLLO2016-09-23
04026704536061PILLINGTELEFLEX INCORPORATEDLLO2016-09-16
04026704530359PILLINGTELEFLEX INCORPORATEDLLO2016-09-16