FDA.reportPublic FDA data

ANCORIS*

Primary DI
10350770003785
Brand
ANCORIS*
Company
Avanos Medical, Inc.
Model
ATAS-12-NSB
Catalog number
ATAS-12-NSB
Device description
Tube Anchor Set, 12 FR
Published
2022-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PYOTape and bandage, adhesive, adjustable closing mechanism, OTC use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UseGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770003785PackageGS110In Commercial Distribution
00350770003788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000378510350770003785
00350770003788003507700037883507700037880350770003788

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

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
true
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
false
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
06971257033698Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033704Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033773Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033780Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033797Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033803Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033810Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033827Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033834Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033841Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
00840118608978ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00840118602273ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00853909006518DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00853909006525DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00350770003757ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003764ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003771ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003788ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003795ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003754ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003761ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003778ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003792ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00842071131036CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00842071131043CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00860001701098PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00860002279626PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00842071130930CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130947CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130954CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04