FDA.reportPublic FDA data

2.0MM ALLOMATE INSTRUMENT

Primary DI
B562KITABSI200
Brand
2.0MM ALLOMATE INSTRUMENT
Company
Wishbone Medical, Inc.
Model
KIT-ABS-I20
Published
2019-09-24
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562KITABSI200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
062355158
Device count
1
DM exempt
false
Premarket exempt
true
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
B562PKBVF050WISHBONE MGPK-BVF052020-07-01
B562PKBVF100WISHBONE MGPK-BVF102020-07-01
B562PKBVF150WISHBONE MGPK-BVF152020-07-01
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B562PKEFC0416S080WishFIXPK-EFC0416S-082023-03-16
B562PKOCD02010AlloMatePK-OCD020-12023-03-16
B562PKOCD02510AlloMatePK-OCD025-12023-03-16
B562PKOCD03010AlloMatePK-OCD030-12023-03-16
B562PKOCD03510AlloMatePK-OCD035-12023-03-16
B562PKOCD04010AlloMatePK-OCD040-12023-03-16
B562066582BWB0Sterile Spine Pedicle Screw System06.6582B-WB06.6582B-WB2022-07-19
B562066587BWB0Sterile Spine Pedicle Screw System06.6587B-WB06.6587B-WB2022-07-19
B56213904001220S00WishBone K-Wire System13-904-001220S-013-904-001220S-02022-07-18
B56213904001220S10WishBone K-Wire System13-904-001220S-113-904-001220S-12022-07-18
B56213904001620S00WishBone K-Wire System13-904-001620S-013-904-001620S-02022-07-18
B56213904001620S10WishBone K-Wire System13-904-001620S-113-904-001620S-12022-07-18

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