FDA.reportPublic FDA data

RELIEVA CIRCA

Primary DI
10705031230989
Brand
RELIEVA CIRCA
Company
ACCLARENT, INC.
Model
EP01
Catalog number
EP01
Device description
RELIEVA CIRCA ETHMOID PUNCH
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAXPUNCH, ETHMOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAXPunch, EthmoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031230986PackageGS15In Commercial Distribution
10705031230989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503123098620705031230986
1070503123098910705031230989

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, single-useA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031063297INSPIRA AIRBC1040ABC1040A2016-09-01
10705031063310INSPIRA AIRBC1440ABC1440A2016-09-01
10705031131996INSPIRA AIRBC0524ABC0524A2016-09-01
10705031132061INSPIRA AIRBC0724ABC0724A2016-09-01
10705031147737INSPIRA AIRBC1240ABC1240A2016-09-01
10705031147744INSPIRA AIRBC1640ABC1640A2016-09-01
10705031206052INSPIRA AIRBC8524ABC8524A2016-09-01
20705031063089INSPIRA AIRBC0524AZBC0524AZ2016-09-01
20705031063126INSPIRA AIRBC0724AZBC0724AZ2016-09-01
20705031063157INSPIRA AIRBC1040AZBC1040AZ2016-09-01
20705031063171INSPIRA AIRBC1440AZBC1440AZ2016-09-01
20705031147703INSPIRA AIRBC1240AZBC1240AZ2018-03-31
20705031242682INSPIRA AIRBC8524AZBC8524AZ2018-03-31
10705031245853TruDi NAV CableTDNC001TDNC0012018-10-31
10705031245877TruDi NAV SuctionTDNS000ZTDNS000Z2019-01-20
10705031245884TruDi NAV SuctionTDNS070ZTDNS070Z2019-01-20
10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031245867TruDi NAV CableTDNC001ZTDNC001Z2018-10-31
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G2231318720Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKAX2023-09-28
G043706480BEARBear-Ent, LLCKAX2022-11-07
G043706490BEARBear-Ent, LLCKAX2022-11-07
G043706930BEARBear-Ent, LLCKAX2022-10-24
G043707260BEARBear-Ent, LLCKAX2022-06-09
G043707270BEARBear-Ent, LLCKAX2022-06-09
G043707280BEARBear-Ent, LLCKAX2022-06-09
G043707290BEARBear-Ent, LLCKAX2022-06-09
G043707300BEARBear-Ent, LLCKAX2022-06-09
G043707310BEARBear-Ent, LLCKAX2022-06-09
G043755000BEARBear-Ent, LLCKAX2022-06-09
G043706100BEARBear-Ent, LLCKAX2022-06-08
G043706110BEARBear-Ent, LLCKAX2022-06-08
G043706120BEARBear-Ent, LLCKAX2022-06-08
G043706500BEARBear-Ent, LLCKAX2022-06-08
G043706510BEARBear-Ent, LLCKAX2022-06-08
G043706520BEARBear-Ent, LLCKAX2022-06-08
G043706530BEARBear-Ent, LLCKAX2022-06-08
G043706260BEARBear-Ent, LLCKAX2022-03-23
G043706270BEARBear-Ent, LLCKAX2022-03-23
G043706280BEARBear-Ent, LLCKAX2022-03-23
G043706290BEARBear-Ent, LLCKAX2022-03-23
G043706300BEARBear-Ent, LLCKAX2022-03-23
G043706310BEARBear-Ent, LLCKAX2022-03-23
G043706320BEARBear-Ent, LLCKAX2022-03-23
G043706330BEARBear-Ent, LLCKAX2022-03-23
G043706340BEARBear-Ent, LLCKAX2022-03-23
B351B755000BEARMytamed, Inc.KAX2021-11-18
B351B706100BEARMytamed, Inc.KAX2021-10-25
B351B706110BEARMytamed, Inc.KAX2021-10-25