FDA.reportPublic FDA data

Veriset

Primary DI
10884521082571
Brand
Veriset
Company
Covidien LP
Model
HP0816E
Catalog number
HP0816E
Device description
Hemostatic Patch
Published
2016-04-15
Public version status
Update
Distribution status
Not 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
LMGAgent, Absorbable Hemostatic, Non-Collagen Based

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMGAgent, Absorbable Hemostatic, Non-Collagen BasedGeneral, Plastic Surgery3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521082571PackageGS16Not in Commercial Distribution
20884521082578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452108257110884521082571
2088452108257820884521082578

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10884521740150LigaSureMRASILF192026-10-01
10884521833098SharkCoreL-19-052026-10-01
10884521159754Nellcor100830582016-09-24
10884521850859Hugo RASMRASC00012026-01-09
10884521850880Hugo RASMRASC00022026-01-09
10884521780170INVOSPMAC71DOC2019-07-31
10884521186033LigaSureLF1212A2016-09-24
10884521744189LigaSureLF1212A2018-05-09
20884521186030LigaSureLF1212A2017-01-06
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031468085SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
30705031468089SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
05413765891380PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891335PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891366PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891373PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
75413765891389PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891397PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
10705031468092SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
10705031468108SURGICELEthicon SàrlLMG2023-05-15
10705031468115SURGICELEthicon SàrlLMG2023-05-15
10705031468122SURGICELEthicon SàrlLMG2023-05-15
10705031468139SURGICELEthicon SàrlLMG2023-05-15
30705031468096SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
30705031468102SURGICELEthicon SàrlLMG2023-05-15
30705031468119SURGICELEthicon SàrlLMG2023-05-15
30705031468126SURGICELEthicon SàrlLMG2023-05-15
30705031468133SURGICELEthicon SàrlLMG2023-05-15
10705031237513SURGICELETHICON, LLCLMG2019-05-13
20705031237510SURGICELETHICON, LLCLMG2019-05-13
10705031237506ETHICONETHICON, LLCLMG2017-08-31
10705031002951SURGICEL NU-KNITEthicon SàrlLMG2016-10-19
10705031002968SURGICEL NU-KNITEthicon SàrlLMG2016-10-19
20705031002958SURGICEL NU-KNITETHICON, LLCLMG2016-10-19
20705031002965SURGICEL NU-KNITETHICON, LLCLMG2016-10-19
00851772007014Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007069Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007144Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007168Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007175Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24