FDA.reportPublic FDA data

I.CO.S®

Primary DI
M248119580ND1
Brand
I.CO.S®
Company
NEWDEAL
Model
119580ND
Device description
The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw head in order to initiate the anchoring of the screw head.
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780051473PrimaryGS10
M248119580ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178005147310381780051473

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephine, reusableAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
536935331
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780045687K-WIRE115071ND115071ND2017-10-09
10381780045731K-WIRE115110ND115110ND2017-10-09
10381780045755K-WIRE115111ND115111ND2017-10-09
10381780045786K-WIRE115170ND115170ND2017-10-09
10381780045809K-WIRE115171ND115171ND2017-10-09
10381780045847K-WIRE115316ND115316ND2017-10-09
10381780045854K-WIRE115416ND115416ND2017-10-09
10381780041771QWIX®119932ND2017-05-26
10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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108101284636428.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636599.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
00190376706467InvictusALPHATEC SPINE, INC.HWK2026-04-09
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00190376706481InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706498InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706504InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706511InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706528InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706535InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706542InvictusALPHATEC SPINE, INC.HWK2026-04-09
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