FDA.reportPublic FDA data

AVANOS

Primary DI
10350770927913
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
92791
Catalog number
61447
Device description
Paracentesis Tray
Published
2020-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030721000QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical Products2003-03-31LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770927913PackageGS14In Commercial Distribution
00350770927916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092791310350770927913
00350770927916003507709279163507709279160350770927916

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1095816020630-202026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1095818020630-242026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095822020640-142026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095823020640-202026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095824020640-242026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095828020644-142026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095829020644-202026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095830020644-242026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095832020645-202026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095833020645-242026-10-20
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542323HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542330HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542347HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542354HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542361HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542378HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542385HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542392HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542408HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542422HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542446HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542453HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542460HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542477HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542484HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542507HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542514HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542521HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542538HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542545HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542552HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542569HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542576HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542583HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542590HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542606HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542620HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542637HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542644HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542651HalyardAVID MEDICAL, INC.LRO2026-11-02