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
10705031063549RELIEVA SIDEKICK LPSDKKLPSDKKLP2016-10-01
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01
10705031200289RELIEVA ULTIRRABC0716RUBC0716RU2016-10-01
10705031200296RELIEVA ULTIRRABC0724RUBC0724RU2016-10-01
10705031205871RELIEVA VORTEX 2RV02RV022016-10-01
10705031237087ACCLARENT NAVWIREGW35150NZGW35150NZ2017-08-01
10705031238701RELIEVA ULTIRRA NAVBC0516RUNBC0516RUN2017-08-01
10705031241008RELIEVA SPINPLUS NAVRSP0516MFSNRSP0516MFSN2018-02-09
10705031241015RELIEVA SPINPLUS NAVRSP0616MFSNRSP0616MFSN2018-02-18
10705031245907TruDi NAVWIRETDNW001TDNW0012019-10-20
10705031462588RELIEVA TRACTRT1040ART1040A2019-05-31
10705031462601RELIEVA TRACTRT1240ART1240A2019-05-31
10705031462625RELIEVA TRACTRT1440ART1440A2019-05-31
10705031462649RELIEVA TRACTRT1640ART1640A2019-05-31
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20

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